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Search Term: Optune

NCT Trial Name# of Centers

NCT02831959

  Effect of TTFields (150 kHz) in Non-small Cell Lung Cancer (NSCLC) Patients With 1-10 Brain Metastases Following Radiosurgery (METIS)
85

NCT02743078

  Optune® Plus Bevacizumab in Bevacizumab-Refractory Recurrent Glioblastoma
11

NCT02974621

  Cediranib Maleate and Olaparib Compared to Bevacizumab in Treating Patients With Recurrent Glioblastoma
9

NCT03033992

  Feasibility Trial of Optune for Children With Recurrent or Progressive Supratentorial High-Grade Glioma and Ependymoma
9

NCT02858895

  Convection-Enhanced Delivery (CED) of MDNA55 in Adults With Recurrent or Progressive Glioblastoma
9

NCT02336165

  Phase 2 Study of MEDI4736 in Patients With Glioblastoma
8

NCT03107780

  MDM2 Inhibitor AMG-232 in Treating Patients With Recurrent or Newly Diagnosed Glioblastoma
8

NCT03276286

  Nativis Voyager for Newly Diagnosed GBM
7

NCT01892397

  Pilot Study of Optune (NovoTTF-100A) for Recurrent Atypical and Anaplastic Meningioma
7

NCT02903069

  Study of Marizomib With Temozolomide and Radiotherapy in Patients With Newly Diagnosed Brain Cancer
7

NCT02977780

  INdividualized Screening Trial of Innovative Glioblastoma Therapy (INSIGhT)
7

NCT03149575

  VAL-083 Phase 3 Study in Temozolomide-Avastin (Bevacizumab) Recurrent GBM
5

NCT03522298

  Safety, Pharmacokinetics and Efficacy of GDC-0084 in Newly-diagnosed Glioblastoma Multiforme
3

NCT02525692

  Oral ONC201 in Adult Recurrent Glioblastoma and H3 K27M-mutant Glioma
3

NCT02847559

  Optune Delivered Electric Field Therapy and Bevacizumab in Treating Patients With Recurrent or Progressive Grade 2 or 3 Meningioma
2

NCT02663271

  TTFields and Pulsed Bevacizumab for Recurrent Glioblastoma
2

NCT02717962

  Study of VAL-083 in Patients With MGMT Unmethylated, Bevacizumab-naive Recurrent Glioblastoma
1

NCT02893137

  Enhancing Optune Therapy With Targeted Craniectomy
1

NCT03128047

  HUMC 1612: Optune NovoTTF-200A System
1

NCT02661282

  Autologous Cytomegalovirus (CMV)-Specific Cytotoxic T Cells for Glioblastoma (GBM) Patients
1

NCT02626364

  Study of Crenolanib in Recurrent/Refractory Glioblastoma With PDGFRA Gene Amplification
1

NCT01954576

  NovoTTF Therapy in Treating Patients With Recurrent Glioblastoma Multiforme
1

NCT01925573

  Optune(NOVOTTF-100A)+ Bevacizumab+ Hypofractionated Stereotactic Irradiation Bevacizumab-Naive Recurrent Glioblastoma (GCC 1344)
1

NCT02343549

  A Phase II Study of Optune (NovoTTF) in Combination With Bevacizumab (BEV) and Temozolomide (TMZ) in Patients With Newly Diagnosed Unresectable Glioblastoma (GBM)
1

NCT03297125

  Assessment of Optune Therapy for Patients With Newly Diagnosed Glioblastoma Using Advanced MRI
1

NCT03174197

  Atezolizumab (aPDL1) + Temozolomide and Radiation for Newly Diagnosed Glioblastoma (GBM)
1

NCT03194971

  NovoTTF Treatment Signatures in Glioblastoma Patients at Autopsy
1

NCT03213002

  Oral Capecitabine and Temozolomide (CAPTEM) for Newly Diagnosed GBM
1

NCT03022578

  Study of Laser Interstitial Thermal Therapy (LITT) in Recurrent Glioblastoma
1

NCT03403803

  Prognosis and Therapeutic Biomarkers for Glioblastoma Patients
1

NCT03405792

  Study Testing The Safety and Efficacy of Adjuvant Temozolomide Plus TTFields (Optune®) Plus Pembrolizumab in Patients With Newly Diagnosed Glioblastoma (2-THE-TOP)
1

NCT01904123

  Trial of WP1066 in Patients With Recurrent Malignant Glioma and Brain Metastasis From Melanoma
1

NCT03452930

  EDO-S101 for MGMT Unmethylated Glioblastoma (nGBM)
1

NCT03477110

  Temozolomide, Radiation Therapy, and Tumor Treating Fields Therapy in Treating Participants With Glioblastoma
1

NCT03501134

  Quality of Life of Patients With Glioblastoma (GBM) Treated With Tumor-Treating Fields
1

Brain Tumor News Articles About Optune

  1. [12/03/2019] Musella Foundation`s Annual Giving Campaign

    This is our #givingTuesday appeal!   The bottom line is that we have helped a lot of brain tumor patients directly - not only with our compassionate use program and copay assistance program, but by offering treatment suggestions, referrals to major centers and clinical trials, offering education via our online forums and our Brain Tumor Guide For The Newly Diagnosed, helped speed up approvals and funded a lot of quality research.  Our programs are critical to speeding up the search for the cure and to help patients deal with a diagnosis of brain tumor. We offer all of this at no cost to the patient, so we need YOUR help. We are only limited by funding. We have projects on the back burner just waiting for funding. We need $250,000 by the end of this year just to cover our compassionate use grant.   We have plans that require a few million dollars in funding, but every dollar helps and even small donations are appreciated.  Check to see if your employer has a matching grants program!

  2. [09/30/2019] Optune Open House  From our good friends at Novocure!  These Open Houses are valuable to anyone who has a brain tumor or knows someone with a brain tumor!  

  3. [08/15/2019] Attend an Optune Open House  From our friends at Novocure.  These open houses are fun and informative!  Worth attending for anyone who has or knows someone with a gbm. Most are live but there are webinar versions in there for people not near a live site!

  4. [07/18/2019] Medicare Releases Final Local Coverage Determination Providing Coverage of Optune® for Newly Diagnosed Glioblastoma
    Medicare published the final rule this morning.  This is the one that we have been battling for the last few months, trying to get them to remove the proposed restrictions.   Medicare listened to every comment  we sent. (Their point by point  response is in the link on the article below), and removed the worst ones.  We can live with it the way it is. Not perfect, but much better than the proposed rule. I call our campaign a win!  The brain tumor community came together on this one.  There were 301 comments submitted, 5 from advocacy groups (including the Musella Foundation), and 209 from patients or caregivers, 80 from doctors!  Very impressive. Thanks!
     
    They removed the big restriction on where you had to go for treatment. 
     
    As for surgery, we commented that some people can't get "maximal debulking surgery". So they did not remove that requirement, but did add the words "where feasible". which effectively removes that one!
     
    They did keep the need to start within 7 weeks of the end of concomitant chemotherapy, but did change from "Temodar" to "chemotherapy",  so those that are use a different chemotherapy are still covered. 
     
    They kept the restriction on using Optune for 18 hours a day but added an exclusion for those days that you have to limit or interrupt treatment,
     
    They did not change the need to have no evidence of progression but in their comments they mentioned the RANO criteria considers pseudoprogression. Reading the RANO criteria closely, for the time period in which the decision needs to be made, it is hard to claim it is progression even if the MRI is 
    worse - so I do not think this will be much of a problem.
    They did not remove the karnofsky score of 70., and the need for it to be a GBM.
    They also added a way for people who were already on Optune and then switch to Medicare can continue if they are using the device and show it is helping.
     
    And they opened the door to appeals if you do not meet any of the criteria!
     
    Overall, much better than I thought we would get, and it was much faster than I thought!  Thanks to Medicare for conducting the process in the right way.
     
     

  5. [07/16/2019] Attend an Optune Open House.  From our friends at Novocure!   

  6. [06/10/2019] Attend an Optune Open House.  These meeting are to learn about Optune and meet people who are using it!  One of them can be done online, the rest are real wolrd. Very much worth attending if you have a GBM or know someone who has one!

  7. [06/01/2019] Correction: Medicare Activism Alert  Sorry - the link in the last news blast did not work so I am resending this article! Please help with this.  We can not let Medicare set a precedent with imposing such severe restrictions.  If they get away with it now, it is only going to get worse for the next treatments in the pipeline – which will probably be much more expensive than Optune.

  8. [06/01/2019] Activism Alert: Big Medicare Problem!

    Please help with this.  We can not let Medicare set a precedent with imposing such severe restrictions.  If they get away with it now, it is only going to get worse for the next treatments in the pipeline – which will probably be much more expensive than Optune.

  9. [05/16/2019] Optune Open Houses  These meetings are for anyone who uses or is thinking of using Optune.  Most of these are live but there are some broadcast on the web!  

  10. [05/09/2019] Medicare proposal to cover Optune for Glioblastoma  We need to fight this.  I will provide details next week!

  11. [04/29/2019] Optune Open House  Here is an updated list of the Optune Open Houses.   These meetings are interesting and a lot of fun for everyone who has  a brain tumor.

  12. [04/09/2019] Optune Open Houses

    This is a chance to learn about Optune - or for those of you using it - to meet others using it and swap tips and ask the experts any questions you have!  Most are live but the last one is a webinar.

  13. [03/14/2019] Optune Open Houses
    These are informative and fun meetings. Some of them are webinars available online for those not close to a live meeting.  All are free.  They are sponsored by Novocure and the Musella Foundation is not involved - I am just letting you know about them because they are important!  


  14. [03/09/2019] Update on Medicare CAC meeting  Stay tuned - I will send out another news blast about this issue when the proposed rule is released! Thanks to those who watched the video on Youtube.  I think that helped. Nobody wants to be viewed as advocating for a 2 tiered health system in the USA where 95% of private insurances pay for Optune but our elderly and disabled won't be able to get it.  Things like that can happen behind closed doors but not when everything is out in the open. Medicare did the right thing with this process. This was the first ever public CAC meeting for a device - they used to do these things behind closed doors.

  15. [03/09/2019] Optune Open House These are nice meetings if you are using Optune or are considering it!  

  16. [03/05/2019] Brain Tumor Advocacy Alert - we need you to watch this video Wednesday Morning 3/6/19 at 9am Eastern Time!   I need everyone to watch this video.  Ask your friends to watch it as well - all on separate devices so each person gets counted. You will probably see a lot of negative things being said about Optune. Take that with a grain of salt. The committee is trying to find an excuse not to pay for it and I doubt if any of the committee members have much experience with using Optune. We will point out the good things in our follow up letters!

  17. [02/27/2019] Medicare meeting about Optune! Tune in this Wednesday March 6, 2019

     On a different issue, a few years ago, the medical director of Medicare told me that we will never get what we want from Medicare because the brain tumor community is not organized enough to apply pressure.  We have to show them that is no longer true.  We finally have a big step forward in the treatment of brain tumors and Medicare doesn't want to pay for it.   This is the most important advocacy issue we face now.   Trying to get additional funding for research is futile if we lose this battle because any new treatments will be expensive and if Medicare doesn't pay we won't have access anyway.



  18. [02/21/2019] Major Advocacy Issue: Optune  

     We can not let Medicare deny access to FDA and NCCN approved brain tumor patients. It sets a dangerous precedent.   

  19. [01/18/2019] Optune Open House, Newton, MA  These are great get togethers for any brain tumor patient or anyone who knows a brain tumor patient!  

  20. [11/10/2018] The role of erlotinib and the Optune device in a patient with an epidermal growth factor receptor viii amplified glioblastoma.  In the case presented, the patient had a GBM but was allergic to Temodar so they had to try something different.   They tried erltinib and Optune, which has resulted in stable disease for at least 9 months after radiation.  It is only 1 case but shows brilliant thinking on the part of this patient's team. They chose Optune, which is the obvious choice, but since the patient overexpressed EGFR, they also added erlotinib.  More research needs to be done on such combinations of Optune and therapies personalized to the patient!

  21. [10/12/2018] Live Facebook Event about Optune on Oct 22, 2018  These events are always interesting to watch!

  22. [10/04/2018] Novocure Announces 55 Presentations at European Association of Neuro-Oncology Meeting 2018

    This shows that Optune has finally hit the mainstream.  55 presentations at the major European brain tumor conference.  Many of these are looking at ways to improve the outcomes, including new types of arrays, new placement of arrays for tumors lower in the skill and for pediatric patients.

  23. [09/06/2018] Optune Open House: St. Louis, MO  These are nice meetings for anyone who has a brain tumor or cares for someone with a brain tumor

  24. [08/29/2018] Optune open house Seattle, WA  These are always very interesting and worth going for anyone dealing with a brain tumor.

  25. [05/29/2018] First results on survival from a large Phase 3 clinical trial of an autologous dendritic cell vaccine in newly diagnosed glioblastoma
    This article is so important that I am placing my editorial comments into the full text part of this entry so more people see it, along with a link to the full article.


  26. [05/20/2018] Brain Tumor Awareness Month Webinar Series: Special Guest Dr Henry Friedman Tonight (Sunday 5/20/18) 7pm Eastern Time!  Just a reminder that it is tonight! Please join us!

  27. [05/18/2018] Brain Tumor Awareness Month Weminar Series: Special Guest Dr Henry Friedman  This is an opportunity to talk to Dr Henry Friedman and ask questions on any brain tumor related topics!

  28. [03/30/2018] Optune Open House, Newton MA  This is a nice series of meetings for patients and caregivers who use (or are thinking of using) Optune.  

  29. [03/20/2018] NCCN Guidelines Recommend Optune in Combination with Temozolomide as a Category 1 Treatment for Newly Diagnosed Glioblastoma  This is great news.  The NCCN basically sets the standard of care for cancer treatments. The NCCN treatments classification is:

    NCCN Categories of Evidence and Consensus

    • Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
    • Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
    • Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.
    • Category 3: Based upon any level of evidence, there is major NCCN disagreement that the intervention is appropriate.
    Not only does this set the standard of care as including Optune, but it should make it impossible for insurance companies to deny it.

  30. [03/16/2018] Musella Foundation Copay Assistance Program reopens!  It will only be open for a few weeks.  If you are thinking of applying, do it now and send it by fax. Do not mail it as you may miss out on it.

  31. [03/09/2018] Optune Open House  This is from the people at Novocure.  It is a facebook event where you can learn about and ask questions about Optune!

  32. [01/29/2018] Optune Open House, Santa Anna, CA  This is from the people at Novocure. These meetings are a perfect introduction to Optune for brain tumor patients thinking about trying it or those who are using it!  

  33. [12/23/2017] Musella Foundation Co-pay Assistance Program Status  If you could use help - do not be shy about asking. These treatments can get expensive.  If you think you need it, apply as soon as possible as the program is going to close quickly.  Send by fax. IF you do not have fax, email it to us, but call us on the phone 888-295-4740 after you email it, and tell us you sent it. We will look for it and fax it for you.

  34. [12/19/2017] JAMA Publishes Final Analysis of EF-14 Phase 3 Pivotal Trial of Optune® Together with Temozolomide Demonstrating Unprecedented Survival Results for Newly Diagnosed Glioblastoma  This is the final report of the Optune trial for newly diagnosed GBM.  It should set the new standard of care for GBM to include Optune.

  35. [12/02/2017] Novocure (NVCR) Announces Reimbursement Approval for Optune in Japan for Treatment of Newly Diagnosed GBM  After the data that they announced at the last SNO meeting (https://virtualtrials.com/newsarticle.cfm?item=6390), it would be criminal for them to not pay for it.

  36. [11/21/2017] High compliance with Optune linked to greatest survival benefit for glioblastoma  There is a dose response curve. (Which also should convince the naysayers that the device is effective)   The better the compliance, the better the patients do. They have been saying 75% is the target compliance rate but the new data shows that 90% should be the target.  Those patients who had a compliance rate of 90% or more, had a survival rate of 29.3% at 5 years, compared to the control group (temodar) which had a 4.5% survival rate, an almost 650% increase in survival rate.
       With a compliance of 70-80%, the 5 year survival rate drops to 19.9%.   Still much better than the control group... so don't stress too much if you can't hit the 90%, but try.

  37. [11/17/2017] Patients Who Used Optune® More Than 90 Percent of the Time Had the Greatest Chance of Survival in Novocure’s EF-14 Trial: A Median Survival of 24.9 Months from Randomization and a Five-Year Survival of 29.3 Percent  A 29.3% 5 year survival - on a large number of patients in a randomized phase 3 trial is very impressive. This shows a dose-response effect, which proves that the concept actually works.  When comparing the median survival, remember that this is from the time that the patients were randomized, not from diagnosis - the difference is almost 4 months. This means that the median survival is almost 29 months, which is a big step forward!

  38. [10/25/2017] Optune trials opens for adult patients with low grade gliomas and pediatric patients with high grade gliomas These are exciting trials.  It is nice to see more research on other uses for the Optune device.  

  39. [09/24/2017] Combination of Optune® with Temozolomide Demonstrates Unprecedented Five-Year Survival for Newly Diagnosed Glioblastoma Patients  The 5 year results for Optune just came out and they were unbelievably good.  This is a large study in newly diagnosed GBM patients so the results are significant. Bottom line: 5 year survival rate was 13% for the Optune (plus Temodar) group and only 5% for the Temodar alone group.  That is a major step forward.

  40. [08/27/2017] OPTUNE OPEN HOUSE - NY Sept 9  This is for anyone thinking about using Optune.  It is a  lecture about the treatment, and there is a patient using the treatment that you can talk to.  It is for patients and caregivers.

  41. [08/14/2017] Options to Treat a Glioblastoma  I was asked for my opinion on what I would do if I had a newly diagnosed gbm.. here is my response.  We can discuss it in the braintumor-treatments online group https://virtualtrials.org/braintumor-treatments.cfm  

  42. [07/24/2017] Novocure™ Announces a Phase 1b Clinical Trial to Evaluate the Safety of Marizomib and Temozolomide in Combination with Optune® as Adjuvant Therapy in Patients with Glioblastoma  All new trials should consider adding an Optune arm. Currently, a few interesting trials are not allowing patients to use Optune at the same time as the trial.  I feel that is not ethical. Optune has been shown to more than double the 5 year survival rate for adult GBM.  If you have to make a choice between trying Optune with a proven benefit and minimal side effects to trying an experimental therapy with no track record and inknown side effects, I would choose Optune.  [Disclaimer: Novocure is a sponsor of the Musella Foundation]

  43. [06/12/2017] First Patient Enrolled in RTOG Trial of Optune® together with Bevacizumab for Patients with Bevacizumab-Refractory Recurrent Glioblastoma  Interesting combination.  I would guess the concept they are going after is that Avastin, when it fails, doesn't just stop working - it just doesn't work enough but still is slowing down the tumor.  If you add Optune, perhaps the combination could be strong enough to stop the tumor.  Hate to say, but it may make more sense to just start Optune at the start - right after radiation - on newly diagnosed people.  For those that missed that opportunity, this trial makes sense. [Disclaimer: Novocure is a sponor of our organizaiton]

  44. [05/01/2017] Musella Foundation Copay Assistance Program reopens!  It will only be open for a few weeks.  If you are thinking of applying, do it now and send it by fax. Do not mail it as you may miss out on it.

  45. [04/17/2017] CNS Oncology Publishes Data Suggesting Survival Benefit of Optune™ in Combination with Second Line Chemotherapies after Glioblastoma Recurrence  This study shows that Optune should be continued after the first recurrence, and use it in addition to a second line therapy.  Patients who had a recurrence and remained on Optune therapy did 31% better than those that discontinued Optune.

  46. [04/03/2017] "Sci-fi" cancer therapy fights brain tumors, study finds  This is the final results of the Optune trial.  Survival rates were 43 percent versus 31 percent at two years; 26 percent versus 16 percent at three years, and 13 percent versus 5 percent at five years. These results are impressive.  The survival advantage has improved since the last report as there are now more 5 year survivors.   All subgroups of patients had a benefit - methylated or unmethylated, young or old, gross total resection and biopsy only.  They also clarified their position of letting every patient who wants to use it get it regardless of ability to pay.

  47. [01/19/2017] Novocure’s Optune® Now Available at 500 Cancer Treatment Centers in the U.S.  That is amazing, as doctors have to take a course to get certified in the use of Optune. This means that practically every major brain tumor center in the USA can offer Optune to their patients.    There was a 70 percent increase in the survival rate at 4 years for newly diagnosed GBM patients, and Optune is now considered the standard of care for newly diagnosed gbms!

  48. [01/19/2017] New Study Aims to Extend TTFields Beyond Grade IV Brain Cancer Domain  It would make sense to use Optune with grade 3 brain tumors - would be nice to see the proof. Good luck with the trial!

  49. [01/03/2017] Musella Foundation Copay Assistance Program reopens!  This program will probably close quickly so if you think you may need it, apply as soon as possible!

  50. [12/31/2016] Top Brain Tumor News Stories for 2016  2016 was an exciting year - but I think 2017 will be the year we see big steps forward! Happy New Year! BTW: The copay program will open again very soon - maybe Monday or Tuesday. Will announce it as soon as it opens!  

  51. [12/07/2016] First report of tumor treating fields use in combination with bevacizumab in a pediatric patient: a case report.  The FDA approval for Optune limited it to use in patients 22 and old because that was the youngest patient in the trial and it hasn't been tested on younger patients. Obviously, it should help younger people.  It can be prescribed for pediatric patients, off label, but insurance companies might try to reject it based on that FDA label restricting age.  Reports like this help us fight the insurance companies! I think the only real limit is the size of the head - the arrays are large and won't fit on a young child.

  52. [11/18/2016] Long-Term Analysis of All 695 Patients Enrolled in Novocure’s Phase 3 Pivotal Trial in Newly Diagnosed Glioblastoma Confirms Successful Interim Analysis Results and Demonstrates Superior Two- and Four-Year Survival Rates  This is what we have been waiting for. The final results of the Optune trial for newly diagnosed GBM.  There was some resistance to accepting Optune as the standard of care because the results presented 2 years ago were "just preliminary". The final results are actually better than the preliminary results! Now the next step is getting insurance to pay for it. Already most non-Medicare plans do pay for it, but Medicare has been hesitating. We had a petition a while ago to help nudge Medicare toward paying for it.  I presented it to them and we did come close and I think it did help - but we had that problem of results being preliminary.  We are going to try again. I resurrected the survey - and updated it to show current results.  Please sign it and have your friends and family members sign it.  IF you already signed it last time - you do not need to sign it again - it is still valid.  If you aren't sure, email me your name and address and I will check it for you.  Go to https://virtualtrials.com/activism.cfm for details and to sign! 

  53. [11/07/2016] United Healthcare Issues Positive Coverage Decision for Optune This has been a big battle to get insurance to pay for Optune.  United Healthcare was basically the last private insurance that didn't pay - now almost all do.  Next up is the Medicare battle.  I have been working on that one for a while and getting closer. I may need your help soon - we are thinking of another petition campaign!

  54. [11/07/2016] Novocure Announces 38 Presentations on Tumor Treating Fields at 21st Annual Scientific Meeting of the Society of Neuro-Oncology  It looks like Optune is finally getting the respect that it deserves. When it was first introduced, I would say most neuro-oncologists dismissed it without looking at data, based solely on preconceived notions that it couldn't possible work.  Now, most seem to at least allow their patients to try it, if not encourage them to try it.  The holdouts tell me that the data is preliminary and they will wait for the full report. Well - that will come out next week!  I did not see it yet, but I assume from this press release that it is favorable.  Hopefully that will remove the last doubt that this should be part of the standard of care for newly diagnosed Glioblastomas. It is very significant that most of the presentations are from researchers not associated with the company.  That shows broad acceptance in the field. 

  55. [09/19/2016] CNS Oncology Publishes Tumor Treating Fields Treatment Planning and Patient Follow-up Guidelines in Glioblastoma This should make the treatment work better - especially for those offices that do not have a lot of experience with using Optune

  56. [09/07/2016] The fourth weapon in the battle against cancer  Nice story about one of the members of our online support group (Brain-novocure)! To join the group, go to https://virtualtrials.com/lists.cfm and select brain-Novocure

  57. [08/31/2016] Musella Foundation Copay Assistance Program reopens!  This program will probably close quickly so if you think you may need it, apply as soon as possible!

  58. [08/16/2016] Novocure Converts More Than 500 U.S. Patients to Second Generation Optune within Four Weeks of FDA Approval on July 13 This should make the Optune system easier to use.

  59. [07/26/2016] NCCN Guidelines Recommend Optune as a Standard Treatment Option for Newly Diagnosed Glioblastoma  I sent a story about this in a recent news blast but this is the press release from Novocure and their take on the topic!

  60. [07/25/2016] NCCN updated CNS cancer treatment guidelines to include Optune  The National Comprehensive Cancer Network is one of the more influential organizations that publishes guidelines for treating cancers.  They just released a new version of the guidelines for CNS cancers and added "Alternating Electric Field Therapy" (which is the Optune system) to their standard of care for newly diagnosed Glioblastoma and Anaplastic Astrocytoma.   When I last met with Medicare over the issue of coverage for Optune, they mentioned the lack of support from the NCCN as one of the reasons they did not want to cover Optune.  Hopefully this removes that issue.

  61. [07/13/2016] Novocure Receives FDA Approval for Second Generation Optune System  I have seen the new system, and it is much nicer. Smaller, lighter, looks much more modern, and is easier to use.  

  62. [05/31/2016] Novocure Receives IDE Approval to Initiate METIS Trial  This sounds like a great combination. Radiosurgery can usually control an individual brain met over 90% of the time, however the patient usually still develops new mets in the brain - because the radiosurgery doesn't do anything for the little islands of tumor cells that you can't yet see on the scans.  The TTFields might be able to stop those islands from developing into new tumors.  

  63. [04/27/2016] Novocure’s Optune Now Available at More Than 360 Cancer Treatment Centers in the U.S.  Looks like Optune should now be available to just about everyone.

  64. [03/03/2016] Humana Issues Positive Coverage Decision For Optune  Humana insures 10 million people in the USA, and now all of these people have access to Optune if they need it!    

  65. [02/21/2016] Treatment with Tumor-Treating Fields Therapy and Pulse Dose Bevacizumab in Patients with Bevacizumab-Refractory Recurrent Glioblastoma: A Case Series.  I do not think this was the best way to set up the study.  The better way of doing it would have been to start Optune a few weeks  after radiation is over, and perhaps try Avastin in a pulse dosing form  - either as newly diagnosed at the same time you start the optune, or at the time of recurrence.  Withholding Optune from a newly diagnosed patient for the purpose of entering a trial like this sounds unethical to me. It shows a lack of understanding of how Optune works. It is a slow, gentle treatment. The time to start it is not when you have a recurrence as it needs a few months to kick in.  The effect of slowing tumor growth starts immediately but it takes time before the tumor starts to shrink.   The trial using it for newly diagnosed patients did much better than the one that started at recurrence. Having said that, the results show that Optune does help when used this way, but I would like to see more trials using it the correct way. For those that missed out on the opportunity to use it when newly diagnosed, this shows that it is worth trying at the time of recurrence.

  66. [02/14/2016] Anthem Inc. Issues Positive Coverage Decision For Optune in Newly Diagnosed Glioblastoma

     Great news.   

    Now that the 3 largest private health insurance carriers in the USA cover Optune, the rest should follow suit soon!  This is a major victory in the fight against brain tumors. We thought the hard part was going to be getting FDA approval because it is a completely new type of treatment, but that actually was easy since the data supported it.  Once that happened, I assumed patients would be able to just get it but the timing was terrible. Insurance companies have just started fighting back against expensive treatments and started denying all new treatments as a way of saving money until they are forced to pay for them. It was a long, hard battle but the people at Novocure persevered and won the battle with the private insurers.

    Next up is Medicare. I had multiple meetings with Medicare and they are getting close to approving payment. The people I met with at Medicare understand that brain tumor patients need this treatment and they are trying to find a way to pay for it. Having the majority of private insurance companies paying for Optune, along with the recent publication of data in the Journal of the American Medical Association, should allow patients to appeal Medicare rejections successfully. IF you have a problem with a Medicare rejection, call me at 888-295-4740 and maybe I can write a letter for you to help with the appeal.

  67. [01/06/2016] Novocure Files Premarket Approval Supplement Application With FDA for Second Generation Optune System  I saw the new system, and it looks like it will make using the system a lot easier!

  68. [11/20/2015] New Phase 3 Data show Optune in Combination with Second Line Chemotherapy is Superior to Second Line Chemotherapy Alone in Glioblastoma Patients at First Recurrence  This is a new report on combining Optune with Avastin. Both are approved for recurrent GBM. The combination reduced the chance of dying by 39% compared to Avastin alone.  This should be the standard for recurrent gbm and investigated for newly diagnosed.

  69. [11/17/2015] Novocure Announces 18 Presentations on Tumor Treating Fields at SNO 2015 Including New Analyses of the EF-14 Newly Diagnosed Glioblastoma Clinical Trial Data Amazing number of presentations for Optune. So glad to see the brain tumor community finally embracing this new treatment option!

  70. [10/05/2015] Musella Foundation Drug Discount Card Update  I went to use the discount card recently and the pharmacist said it was invalid, so I checked and the PDF version had a digit missing, which the plastic cards we distribute had correctly.  So I fixed the PDF and now both the plastic cards and the pdf should work. For the PDF, you just pull it up on your smartphone and show the pharmacist!

  71. [10/05/2015] FDA Expands Optune`s Glioblastoma Multiforme Indication  Fantastic news! The FDA acted quickly! They approved Optune for Newly Diagnosed Glioblastoma to be used in addition to the standard treatment!  It results in "the risk of progression or death was reduced by 37 percent "

  72. [10/05/2015] Novocure Announces CE Mark and First Patient Use of Second Generation Optune System  The second generation Novocure device is now available in Europe. Hopefully will get FDA approval to use it in the USA soon!   It is half the size and weight of the old system, and looks a lot better!

  73. [09/12/2015] Novocure to Present the Latest Data from the EF-14 Clinical Trial in Newly Diagnosed GBM at the 15th Interim Meeting of the World Federation of Neurosurgical Societies  This updated the results that were presented last year.  They still look great!

  74. [09/08/2015] Novocure Announces Optune® Now Available at more than 200 Leading Cancer Centers across the United States  This is a big milestone for the Optune system.  This treatment is now available in most areas of the USA. If it isn't available near you, you can ask your doctors to get certified.

  75. [06/27/2015] IBTA Newsletter  From our good friends at the IBTA

  76. [05/31/2015] Novocure Announces First Analysis of Full 700 Patient Dataset from Successful Newly Diagnosed GBM Phase III Trial  This confirms the good results they reported in the interim analysis a few months ago. 2 year survival for newly diagnosed GBM patients went up from 29%  in the standard therapy group to 43% in the standard + Novocure group.  More of the details will come out on June 2, 2015.  When I discussed the interim results with neuro-oncs , many took the cautious viewpoint of "wait for the full results - it can't be that good".  Well - these are the full results and almost as good as the interim results.  They also had concern that perhaps a major difference in prognostic factors between the control group and treatment group might account for the difference. Hopefully we will find out in a few days when more details are released. 

  77. [05/28/2015] Novocure Announces Commercial Launch of Optune (the NovoTTF-100A System) in Japan  Optune is now available in Japan!

  78. [05/13/2015] NCCN Guidelines Recommend Tumor Treating Fields as a Standard Treatment Option for Recurrent Glioblastoma Novocure  This is a good first step but way too little. The NCCN guidelines should have made it a standard treatment for both newly diagnosed as well as recurrent glioblastoma. The upgrade from Category 3 to Category 2B will help with insurance coverage issues, but again, they are too conservative and should have upgraded it to a Category 1, which should eliminate all insurance issues and allow access to everyone who needs Optune..  Hopefully when the results of the recent phase 3 trial for newly diagnosed GBM patients is published, they will revise the guidelines again and give it a Category 1 for both newly diagnosed as well as recurrent GBM.

  79. [05/11/2015] FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma  This is great news.  Hopefully the FDA will quickly approve the Optune system for newly diagnosed GBM patients. Right now it is only approved for recurrent GBM patients but with results like this ( a 48% increase in 2 year survival rate), of course newly diagnosed patients should be using it. Newly diagnosed patients can use it now off label.  I just had a patient request my help in fighting his insurance company - they rejected the claim for Optune for his newly diagnosed GBM saying it is experimental for newly diagnosed.  I sent a nice letter along with the research and they reversed the decision, saying they will now pay for it.  Getting the FDA - then the NCCN - to support it's use for newly diagnosed will speed things up and avoid that problem.

  80. [04/25/2015] New Optune You-Tube Video Channel  There is a new video on that page which shows the effect Optune has on dividing cancer cells. They show cancer cells in culture dividing, the ones on the left are treated with Optune, the ones on the left are not treated.  Aside from the amazing video of showing cells blow up when they try to divide, the end result is a huge reduction in the number of tumor cells at the end.

  81. [12/21/2014] Novocure Announces Optune Now Available at more than 150 Leading Cancer Centers across the United States  There are now  over 150 centers certified to use Optune, including some of the best in the world, now making it much easier to find a center close to you  

  82. [12/17/2014] At a Turning Point: Novel Therapeutic Developments in Glioblastoma Multiforme (GBM) Research : Conference posted online!  This was one of my favorite conferences.  It was for MDs, not patients, but advanced patients will be able to understand most of it.  If you are new to the world of brain tumors, start off with the lectures from our 11/12/2013 patient conference. After watching them, you will be able to understand a lot of what is going on in this new conference.   The videos work in Internet Explorer and Chrome now, but not firefox. I am working on that. Let me know if you have trouble with any other browsers.

  83. [11/19/2014] Al Musella`s Brain Tumor Blog on SNO2014  This is my thoughts on the exciting news from SNO this week!

  84. [11/15/2014] Novocure Announces the EF-14 Phase III Clinical Trial of Tumor Treating Fields in Patients with Newly Diagnosed Glioblastoma has been Terminated at the Interim Analysis due to Early Success

    This is historic.  As far as I know, and I have been involved with brain tumors for 22 years, this is the first time a GBM trial was ever stopped early because it actually worked!  Optune – the new name for the FDA approved Novocure tumor treating field device, has finally shown what it can do.   This was a large phase 3 randomized trial comparing the standard “Stupp Protocol” to the standard + the Optune device.  There are many ways to look at the results (see the article for the rest)  but keep in mind the numbers given are from the time the trial started, not from the date of diagnosis. The trial started around 3.8 months after diagnosis.  There was an increase of about 50% in the number of patients alive at 2 years after starting treatment ( about 27.8 months after diagnosis) ,  from 29% in the Temodar group to 43% in the Optune group.  Overall survival increased by about 3 months, from 16.6 to 19.9 months after trial started ( or about 20.4 to 23.7 after diagnosis).   

    Dr Stupp presented the data and then said "a new standard of care for patients with GBM has been established", and  "A new cancer treatment modality has been born".  He called it a paradigm shift.

    The last time the standard of care changed was in 2005  when Dr Stupp presented his data on using Temodar at the same time as radiation, in addition to the old way of using Temodar.  That resulted in a gain of 2.5 months, from 12.1 months to 14.6 months from diagnosis.

    My opinion is that this is a big step forward, with very little downside. This is the first non-toxic therapy ever to succeed in a phase III trial for newly diagnosed cancer patients.  I agree it should be the new standard of care.  Of course a lot more work needs to be done but we have to go with the best we have at the time and this is it. I hope to see more trials combining other treatments with Optune – hopefully also with no or low toxicities.  This brings us a step closer to our goal of a cure.

    Talking to many of the doctors present at the meeting, there were still a few who said they wouldn’t use it. The main objection now is that it may interfere with clinical trials.   I would suggest designing trials to allow for the use of Optune just as they had to do when the standard of care changed 9 years ago.  I am a huge supporter of clinical trials but if there is a choice between using Optune and having minimal or no additional side effects with a known average benefit of a 50% better chance of living at least 2 years, vs. a clinical trial which has unknown side effect profile and unknown benefit in survival, I would probably choose the Optune. 

     If you decide that you want to try this treatment, ask your doctor about it but if they seem resistant to the idea, go to http://optune.com to find a doctor in your area that is trained to use it and get another opinion. This treatment has been FDA approved for recurrent glioblastoma, but it can be prescribed off label for newly diagnosed. Clearly the earlier you start it the better the outcome.  Hopefully the FDA will approve it for newly diagnosed GBM soon!

     

         Disclaimer: Novocure is a sponsor of the Musella Foundation but I have never personally received anything of value from them.





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