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.
|
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. |
