My comments at the FDA ODAC on MRD as an accelerated approval endpoint in Myeloma

Safety is the big reason this is a bad decision

Dr Amol Akhade Here are my concerns
youtu.be/-42d0z9faao

Vinay Prasad MD MPH Deaf ears don't hear.

Vinay Prasad MD MPH Worked for a pharma company whose drug had an adverse event signal in a clinical trial in pregnant women.
There were protests in streets and scientific meetings by activists and patient advocacy groups demanding the drug's FDA hold be lifted.
Guess who was funding these groups?

Vinay Prasad MD MPH My concern is that the FDA's Oncology Director explained accelerated approval (AA) in a way that conflicts with the agency's website when he said that AA is about treating serious and life-threatening diseases sooner without consideration for unmet need. Is anyone going to…

It was a partnership between pharma, the industry, patient organizations funded by pharma, and the FDA!

Biggest concern is active drugs w uncertain safety given to people with 10+ yrs of life. Neurotox for a decade will be horrible.
youtu.be/-42d0z9faao

Here are my concerns with today's FDA action
It's not surprising because FDA's primary client are the drug companies, and this will enrich them
youtu.be/-42d0z9faao

Samer is correct
The only association remotely good had 7 data points
Whole meeting
MRD is not a suitable surrogate
Its always a strange discussion because FDA oncology makes sure to limit the opposing view

Appreciated your commment on toxicity David Mitchell
I think the data that deeper first response means longer life is flawed, and a false story propagated by pharma. regarding your other comment. The poor R2 for MRD and OS proves it is false

Weird to see FDA discus the P13k failure because their inaction left it on the market for years, as we document in a JAMA Internal Medicine
jamanetwork.com/journals/jamai…

I want drugs to reach patients with cancer faster also. However, I want these drugs to be safe. I want to know that when I prescribe them they are resulting in net benefit and be confident I am not causing harm.

Vinay Prasad MD MPH I also think Pazdur just mispoke about unmet medical need not being part of the regulation.
Per FDA: 'The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate…

Rick Pazdur says that Unmet medical need is not a prerequisite for Accelerated approval. I guess he should edit the FDA's website then
fda.gov/drugs/nda-and-…

Rick Pazdur is wrong that randomization and following OS is a safety safeguard. That only works if the post protocol therapy is not substandard. If post protocol therapy is negligent, a drug with toxicity deaths but keeps you on backbone longer may look like it has favorable OS,…

ODAC panelist speaking now says we need fast approvals so drug companies can recover costs for longer time, otherwise they would have to charge more

LOL who do these people work for?

Vinay Prasad MD MPH U.S. FDA #ODAC meeting explains why acceptance of MRD in MM trials would be a poor idea for accelerated approvals

Vinay Prasad MD MPH very provocative point of view. With the increased coverage of the rising rates and early detection across types of cancer, not enough discussion on the survival gains or the breadth of the drug class(es) to treat multiple myeloma.

Great speak from Vinay Prasad explaining why the FDA should NOT use MRD for accelerated approval in MM, and should instead shield patients from potentially very toxic drugs in patients with outcomes that have improved so much over the last 2 decades !!
👇👇👍