A key, as I see it now, is determination of policy that helps us to best meet the goal of getting better therapies to pts as fast as we can responsibly do so. There are current differences in opinion on *how best to do this*, but I definitely see no conspiracies.
"Not only politicians, regulators, scientists, doctors and pharmaceutical officers get cancer, but their parents, siblings children, grandchildren and best friends - so we have an interested majority in any group you can think of - and we have to work the system by speaking up, being active and letting them know that we care and that we expect them to do their best to deal with this devastating plague in our society.
Join us next year in D.C."
- Leonard R.
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Corixa Bexxar Review For Non-Hodgkin’s Lymphoma Set For Half-Day Meeting
GlaxoSmithKline/Corixa’s Bexxar BLA for non-Hodgkin’s lymphoma will get a half-day review by FDA’s Oncologic Drugs Advisory Committee on Dec. 17 starting at 12:30 p.m.
The committee is likely to review the analysis of case reports submitted by Corixa from patients with long-standing durable responses to Bexxar (tositumomab). The case reports were submitted to the agency in an appeal of FDA’s March 12 "complete review" letter for the radiotherapy, which concluded that additional trials would have to be conducted to support approval of the product. ... Full text: fdaadvisorycommittee.com
BACKGROUND
This page contains information about the FDA decision to turn back the approval of Bexxar and require additional testing. This came as a shock to many of us because we have read mostly positive news about the drug (see below), and we know first-hand the urgent need for effective drugs.
I don't think we have to know the reasons for the delay to speak out. Perhaps it is justified; perhaps not. There are many factors that must be accounted for: safety, efficacy, shipping, manufacturing quality ... and the needs of the patients. However, I believe that the last factor is key. If we don't communicate the experience of low grade NHL -- diminishing response & duration of response to toxic treatments -- how can the FDA and our representatives make truly informed decisions? You can click the link below to review the letter I wrote to the FDA that summarize the expressed concerns of the patient community.
- Karl Schwartz
REMINDER: The law forbids the FDA to disclose the reasons for a denial to approve a drug. However, the company can do so. Corixa may issue a statement soon.
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