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FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma

Al's Comment:

 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.


Posted on: 05/11/2015

11 May 2015

FDA Grants Priority Review Status for Novocure’s PMA Supplement Application of Optune in Newly Diagnosed Glioblastoma

 

PMA Supplement application for Tumor Treating Fields in combination with temozolomide chemotherapy for newly diagnosed glioblastoma accepted for filing and review

St. Helier, Jersey – May 11, 2015 – Novocure, a commercial stage oncology company, announced today that its Premarket Approval (PMA) application for Optune has been accepted for filing and review and granted priority review status by the United States Food and Drug Administration (FDA). The PMA application seeks approval for Tumor Treating Fields (TTFields), in combination with temozolomide chemotherapy, as a first-line treatment for glioblastoma (GBM). The submission is based on the successful interim analysis of EF-14, a randomized, Phase III trial comparing TTFields plus temozolomide to temozolomide alone in newly diagnosed glioblastoma.

The FDA’s granting of priority review status means that the PMA application is placed at the beginning of the appropriate review queue and receives additional review resources, as needed. This status is granted to devices that are intended to treat a life-threatening disease and which offer significant, clinically meaningful advantages over existing approved alternatives. The FDA also confirmed that a filing review was conducted and the PMA application was found to contain all of the information needed to proceed with substantive review.

"The FDA has been extremely responsive in working with Novocure on the Optune PMA supplement and we appreciate their partnership. We are very pleased to have received priority review and are fully committed to working closely with the FDA to ensure that Optune is approved as quickly as possible for newly diagnosed GBM,“ said Asaf Danziger, Chief Executive Officer of Novocure. “The FDA’s acceptance of the PMA supplement application for Optune is a very important milestone for Novocure and an even more important milestone for patients suffering from GBM who are in need of new and effective treatments.”

The pre-specified, interim analysis of EF-14 showed that:

  • The percentage of patients alive at 2 years in the TTFields together with temozolomide arm was 48% higher than in the temozolomide alone arm.
  • Patients treated with TTFields together with temozolomide demonstrated a significant reduction in risk of progression or death compared to temozolomide alone (median PFS of 7.1 months compared to 4.0 months, hazard ratio=0.63, p=0.001).
  • Patients treated with TTFields together with temozolomide demonstrated a significant reduction in risk of death compared to temozolomide alone (median OS of 19.6 months compared to 16.6 months, hazard ratio=0.75, p=0.034).

About Glioblastoma
Glioblastoma (GBM) is the most common form of primary brain cancer with approximately 10,000 patients diagnosed each year in the U.S. Overall survival with standard of care temozolomide chemotherapy alone is approximately 15 months.

About Tumor Treating Fields Therapy
Tumor Treating Fields (TTFields) therapy is delivered by a portable, non-invasive medical device designed for continuous use by patients. In vitro and in vivo studies have shown that TTFields therapy slows and reverses tumor growth by inhibiting mitosis, the process by which cells divide and replicate. TTFields therapy creates low intensity, alternating electric fields within a tumor that exert physical forces on electrically charged cellular components, preventing the normal mitotic process and causing cancer cell death.

Approved Indication
The US FDA has approved the TTFields therapy delivery system, Optune (previously known as the NovoTTF-100A System), for use as a treatment for adult patients (22 years of age or older) with histologically-confirmed GBM, following histologically or radiologically-confirmed recurrence in the supra-tentorial region of the brain after receiving chemotherapy. The device is intended to be used as monotherapy, and is intended as an alternative to standard medical therapy for GBM after surgical and radiation options have been exhausted. Patients should only use Optune under the supervision of a physician properly trained in use of the device. Full prescribing information is available at www.optune.com/safety or by calling toll free 1-855-281-9301.

About Novocure
Novocure is a private Jersey Isle oncology company pioneering a novel therapy for solid tumors called TTFields. Novocure’s US operations are based in Portsmouth, NH and New York, NY. Additionally, the company has offices in Switzerland and Japan and a research center in Haifa, Israel. For additional information about the company, please visit www.novocure.com or follow us www.twitter.com/novocure.

 


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