IBTA April 2010 E-News
Posted on: 04/15/2010
IBTA April 2010 E-News
Dear Friend of the International Brain Tumour Community
Avastin Canada: “Roche Canada announced today that Health Canada has approved AVASTIN(R) (bevacizumab), as a single agent, for the treatment of patients with glioblastoma multiforme (GBM), the most aggressive primary malignant brain tumour, after relapse or disease progression, following prior therapy. AVASTIN has been issued a notice of compliance with conditions (NOC/c), pending the results of confirmatory studies to verify its clinical benefit. Products authorized under Health Canada's NOC/c policy are intended for the treatment, prevention or diagnosis of a serious, life-threatening or severely debilitating illness. They have demonstrated promising benefit, are of high quality and possess an acceptable safety profile based on a benefit/risk assessment. Health Canada has provided access to this product on the condition that the sponsor submit the results of additional clinical trials to verify the benefit within an agreed upon time frame.” Source CNW 24 March 2010.
Avastin - Australia: Roche in Australia has developed a country-specific cost-sharing program, which commenced on 15 March, for Avastin for GBM patients after relapse or disease progression after standard therapy, including chemotherapy. This announcement follows approval of Avastin for that indication.
Brain Tumour Patients’ Charter of Rights: Sunday 18 April is the 4th European Patients’ Rights Day and the IBTA will use the occasion to launch a Brain Tumour Patients’ Charter of Rights which will have a universal application as an aspirational document. The Charter will appear in the IBTA’s forthcoming magazine (see later). We would like to thank those who responded to our major survey directed to all our contacts and the recent mini-survey about the Charter directed to our patient, caregiver, support group and advocacy contacts. The Charter has undergone 13 iterations as we strive to achieve the appropriate words applicable for most cultures.
Childhood cancer drugs for brain tumours: Pharmaceutical Research and Manufacturers of America (PhRMA) member companies currently have 234 new medicines in development for the special health care needs of children, the industry group said yesterday. IBTA E-News looked at the PhRMA list, which is available for download from its website and those listed that appear to be directly relevant to brain tumours are: irinotecan, cintredekin bseudotox, and nimotuzumab. Those being looked at generally for solid tumours are: cetuximab, perifosine, taxotere, panitumumab and robatumumab. Not a large number unfortunately.
IBTA magazine: The IBTA has been working on a magazine planned for worldwide distribution in the brain tumour community. It will be printed on 26 April in the UK and comprise at least 80 pages, written in an easy to read style with plenty of photographs. There are short interviews with more than 20 brain tumour support group leaders and more than 15 clinicians and surgeons from various countries.
It contains some fascinating information from people who are everyday names in the brain tumour community. For example, who is the neuro oncologist who tries to run at least two marathons each year? The one who competes in ironman events? The neurosurgeon who likes to ride fast on a motorbike? The Board member of a brain tumour charity who repairs antique clock movements as a hobby? There are also inspiring articles from patients who are getting on with their lives and other articles of interest to practitioners, researchers, company managers, and patients alike.
The IBTA intends to post a copy of the magazine to everyone on our database for whom we have addresses and to send multiple copies to the larger institutions, treatment centres and patient groups. You will soon receive an email invitation to respond to a Zoomerang survey from the IBTA seeking your postal (land) address and recommendations for centres to which multiple copies could be sent. Please respond to ensure you receive a copy of the magazine and that it reaches the audience for whom it is intended.
Epidemiology meeting: IBTA Co-Director Kathy Oliver recently attended a meeting of the Brain Tumor Epidemiology Consortium (BTEC) held at Cambridge, UK. She reports that nearly 50 specialists including epidemiologists, neurosurgeons, pathologists, researchers and others from around the world attended this 12th annual meeting, the theme for which was "Low Grade Gliomas" (LGGs). It is an indication of the greater focus of attention being put on this type of brain tumour that The Cancer Genome Atlas (TCGA) Project -which had previously prioritised glioblastoma multiforme, ovarian and lung as the first cancers to study - is now including LGGs and other types of gliomas in addition to GBM in its work. See http://cancergenome.nih.gov/wwd/cancers_studied_by_tcga.asp Additionally, epidemiologist Dr Margaret Wrench (USA), Co-President of BTEC said at the conference at Cambridge: "This meeting has shown tremendous development in our knowledge of possible risk factors for glioma, for example through inherited susceptibility as investigated in the Gliogene [brain tumour familial risk] project and the Genome-Wide Association Studies (GWAS). We are at a point where we may be able to figure out this disease and that is really very hopeful."
Continuous dose-intensive TMZ: Dr James Perry (Canada) and colleagues give an update in the 22 March issue of the Journal of Clinical Oncology on the RESCUE study, involving continuous dose-intensive temozolomide in recurrent malignant glioma. They report: Rechallenge with continuous dose-intense TMZ 50 mg/m2/d is a valuable therapeutic option for patients with recurrent GBM. Patients who experience progression during the first six cycles of conventional adjuvant TMZ therapy or after a treatment-free interval get the most benefit from therapy. In an editorial comment Dr Patrick Wen (Boston) expresses caution, while acknowledging that the RESCUE regimen shows promise. Other relevant trials in progress include the RTOG 0525 study (due in 2010) and the German DIRECTOR study.
Response Criteria for High Grade Gliomas: In the April 10, 2010 issue of the Journal of Clinical Oncology members of the Response Assessment in Neuro-Oncology (RANO) Working Group present their proposal for updated response criteria in high-grade glioma but advise that it is a “work in progress”. The Macdonald Criteria was previously used in clinical trials. Patient groups should study these proposed criteria to evaluate how they might impact on existing practices. One example includes eligibility for entry onto trials for recurrent glioma. Currently patients are accepted if there is any worsening of their imaging studies, the RANO group proposes “that patients should be required to have a 25% increase in the sum of the products of perpendicular diameters of the contrast-enhancing lesions, while on stable or increasing doses of corticosteroids ...”.
US brain tumor statistics: The Central Brain Tumor Registry of the United States has published its latest report on primary brain and CNS tumors diagnosed in the USA in 2004-2006. The report is downloadable from here.
Generic Temozolomide: On 31 March Teva UK announced the availability of a generic form of Temodal (Temozolomide) in 5mg, 20mg, 100mg, 140mg, 180mg and 250mg strength capsules. In other developments The European Commission granted a marketing authorisation valid throughout the EU for Temozolomide Hexal (another generic) to Hexal AG on 15 March 2010; to Hospira UK for Temozolomide Hospira (another generic) on 15 March 2010; and to Sandoz Pharmaceutical GmbH for Temozolomide Sandoz (another generic) on the same day.
Vietnam: A dissident Vietnamese Catholic priest, 63 year old Nguyen Van Ly, has been released from prison in Vietnam to undergo treatment for his brain tumour but it is unclear if he must return if he gets better. His sister says he had three strokes last year. He had been held in solitary confinement for three years. Last year Democrat Senator Barbara Boxer spearheaded two letters in the (US) Senate to Vietnamese President Triet and the Vietnamese Ambassador to the United States, Le Cong Phung urging the immediate release of Father Ly.
Thank you for your continuing support.
Denis Strangman (Chair and Co-Director)
International Brain Tumour Alliance IBTA
Kathy Oliver (Co-Director)
PO Box 244, Tadworth, Surrey
KT20 5WQ, United Kingdom
Tel:+ (44) + (0) + 1737 813872
Fax: + (44) + (0) +1737 812712
Mob: + (44) + (0) + 777 571 2569
The International Brain Tumour Alliance is a not-for-profit, limited liability company registered in England and Wales, registered number 6031485. Registered office: Roxburghe House, 273-287 Regent Street, London W1B 2AD, United Kingdom. All correspondence should be sent to the Co-Director’s address above, not to the registered office.
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