Sunday, August 3, 2014

So -- What Is On Tap, At The NON-Public (And Not Yet Announced?) Portions Of FDA's Sept. 18 Advisory Committee Meeting? And Whither A Morning Session?

File this one under the header "Sometimes, What Is Not Said -- Is More Meaningful Than What Is. . ."

So, it is possible (likely even) that in the very near future, at FDA's public website on Advisory Committee calendars and materials -- this Cellular, Tissue and Gene Therapies Advisory Committee meeting agenda will be extended -- to a full day. At the moment, it is a 1 PM to 4 PM affair. Seems unusual to have all these fine folks gathered (many of them having traveled, overnight, the night before -- and available first thing that morning -- the 18th) for just a couple hour afternoon session, right? Right.

But in order for pembrolizumab to clear FDA by October 28, 2014, a committee meeting with a Mid-September date is needed. This one would serve nicely as an update on the rolling FDA submission from Merck, on pembrolizumab. So will that occur, at some point, at this meeting? Who knows? If it does, it is also possible (if not quite as likely) that the committee will take a look at the BMS nivolumab data sets thus far adduced.Only about two and a half hours of the day long meeting are open to the public. So, it would be natural to ask whether this meeting date is tied to the indicated October 28, 2014 FDA "breakthrough" decision date for Merck.

In addition (to further butress my guess at right), I think I highlighted this fine writeup, from the OBR Blog, back in June -- on what most experts see in the PD-1 melanoma races:

. . . .Although Merck’s submission might allow pembrolizumab to beat nivolumab to market in the relapsed/refractory setting, nivolumab still might ultimately prevail as it is being examined in two Phase III trials in newly diagnosed and relapsed/refractory settings. If one or both of these trials are successful, nivolumab could enjoy strong utilization in frontline and, as a consequence, keep pembrolizumab confined to later lines of therapy. Recognizing the drawbacks of potential confinement to later lines of therapy, Merck decided to challenge Yervoy by initiating a Phase III trial (NCT01866319) in September 2013 that will evaluate two dosing schedules of pembrolizumab (10 mg IV, either once every two weeks or once every three weeks) versus Yervoy in 645 Yervoy-na├»ve patients with unresectable or metastatic melanoma. This study includes patients who will receive first- or second-line treatment, with PFS and OS as co-primary endpoints. While going head-to-head with Yervoy is a good strategy, the combination trial of nivolumab and Yervoy currently poses the main threat for pembrolizumab. Data reported at ASCO 2014 showed an unprecedented two-year survival rate of 79% for the combination (as well as 43% ORR with 17% CR), which appears superior to pembrolizumab. . . .

Of course, each candidate is busily amassing solid data in other cancer types -- lung cancer being chief among these. Do stay tuned. We will update you right here, if/when FDA offers additional translucency on the September 18, 2014 Advisory Committee agenda. And now it's. . . bike and beach time!


Anonymous said...

Interesting article~your thoughts?

Condor said...

Hey Anon. --

Thanks! This is an excellent, and balanced look at a vexing problem.

I'll likely write a full post on it late this evening, after the day gig is put to bed, but I do think Gilead's pricing, while high, is not "off the chart" -- given the overall costs of Hep C, left untreated.

As the article points out though, the insurer paying the $84,000 today, may not be the same payer who receives the benefit of the healthy patient (i.e., no liver transplant costs) dwon the road.

Thus the hue and cry.

I still think we should cure everyone we can.

What do YOU think? do tell!

Namaste, and do stop back!

Anonymous said...

Short: I agree.

Long: I wish we (the country) could have a serious discussion on how we pay out for medical care. Yet, we only seem to 'bite and snap' at each other. In this case, I see the numbers clearly favoring treatment. I guess we don't really talk because, we would have to address issues on, at least, every other year.