FDA panel wants stricter standards on cancer drugs

[Guest guest]

If you think CLL drug approval is slow now... it looks like it is going to get

slower...

Drug companies are in some cases failing to do the required post-approval

(fast-track) trials...

quote:

Randomized, controlled trials should be the default position for all trials, "

said panelist Lyman, MD, PhD, director of the Duke Comprehensive Cancer

Center in Durham, N.C. " We're not doing anyone a service doing single-arm trials

when a trial with a control could easily be done. "

We frequently get sponsors [drug companies] who say 'What's the lowest number of

patients and response rates you'll take?' " said Pazdur, MD, the

director of the FDA's Office of Oncology Drug Products.

end quote:

Source Article

http://www.medpagetoday.com/Washington-Watch/FDAGeneral/24775

~chris

~chris

[Guest guest]

The WSJ site might require a subscription? ... this article, atypically for WSJ

content I think, seems a fairly balanced account of the issues:

http://online.wsj.com/article_email/SB10001424052748703313304576132560915752074-\

lMyQjAxMTAxMDAwOTEwNDkyWj.html

At issue is how to make sure the sponsors carry out the confirmatory studies ...

which I think serves the patient interest by identifying drugs that harm instead

of help us.

So far the track record is good: 27 of 49 post-market studies confirming benefit

for drugs that won accelerated approval, but a good number of completed studies

(7) haven't confirmed a benefit, and a good number haven't been done.

For bexxar, I think the issue here is we have arguably a home run drug for a

common lymphoma -- that is not a commercial success (oncologist don't prescribe

it for many reasons too complex to go into here) ... so in this case, the

sponsor citing the challenge of enrolling patients seems disingenuous - even if

this challenge often applies for other drugs, particularly for the less common

indications.

.... Here, frankly, the sponsor seems more interested in researching ofatumumab

- perhaps because like rituxan it might be prescribed more often, again and

again as maintenance ... where bexxar is given once, typically, and only be

oncologists trained in nuclear medicine.

My take is that patients should make sure that FDA doesn't operate by formula -

assuming that sometimes a single arm study will be the best we can do for the

rarer cancers (or the only ethical way to conduct a study for some kinds of

agents)... and that surrogate endpoint can be reasonable in these cases,

particularly when there are no effective alternatives and little hope of

completing a randomized study for the indication.

But I think requiring the sponsor to make a good faith effort to confirm the

results (when feasible) is in our interests and it should not slow down the time

it takes to evaluate new drugs for accelerated approvals. The rate limiting

factor being patient enrollment.

Karl

>

> If you think CLL drug approval is slow now... it looks like it is going to

get slower...

[Guest guest]

I think that the European model may be the answer. Allow drugs to be

conditionally approved

for a year. This would force the drug companies to live up to their end of the

deal...

After that, review the progress and reassess the situation...

No benefit or failure to provide the necessary information, then remove the

approval.

~chris