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February 17, 2014 at 4:33 pm #21804
Ok, I think I have some more definitive news. Merck is FILING in June for PD1 approval with the FDA. How long that takes for approval is anyone’s guess. Shouldn’t be too long. There is no definitive date on EAP (expanded access) yet for this but hopefully soon. In the meantime their trials are closed.
BMS PD1 has a few openings scattered across the country. Moffitt has some openings in IPI refractory (didn’t respond) and several other requirements. So stay tuned as we find out more.
PDL is just coming onto the trial frontier. Check clinicaltrials.gov for any updates
I will keep my ear to the ground and make sure that we have accurate information to provide you.February 17, 2014 at 7:33 pm #63582EricW1Participant
I was wondering when does the EAP come into play if it does at all? Is it when they file or is it sooner? Do you have any idea how that process works? ThanksFebruary 17, 2014 at 8:06 pm #63583
A company sponsoring a drug Phase III clinical trials, can offer expanded access programs for patients before the approval goes through for prescription.
The FDA generally approves these EAPs if the drug has shown that it works at least somewhat to treat cancer in the clinical trials that are being done. This can allow a lot of people access to the unapproved drug, as long as they meet the requirements of the EAP.
This was the scenario of IPI. We may see an EAP from BMS too. So this would all be a good thing, but when exactly, no one really knows. I will post when I find out though!February 17, 2014 at 8:27 pm #63584EricW1Participant
ThanksFebruary 18, 2014 at 10:21 pm #63585jamesaParticipant Catherine,
This is very exciting news for people like Jonathan, Sylvia & Amy, and many others. I am so happy for all the folks needing PD1.
BTW, have you heard which trial Amy decided to do?
Also, did Merck confirm to you that when the FDA approves Merck PD1 that a patient must first “progress” after taking IPI? I hope not, this would be yet another obstacle for patients to get PD1. Clearly, PD1 has a better response rate than IPI so why should a patient first have to progress on IPI before getting PD1?
See MattR statement below from another post replied:
Re: Anti-PD1 after Ipi
Postby MathewR » Tue Feb 18, 2014 3:04 pm
There is obviously a lot of excitement and anticipation regarding the approval of anti-PD-1 (me too!). As noted by others, from the media reports, it seems like Merck is in the lead with intent to file with the FDA by June. However, from everything I’ve seen on this, the approval will be limited to patients who have previously been treated with ipi (and progressed–see the quote pasted below from a recent Forbes interview with MRK’s head of R&D). One might speculate that BMS will seek a similar limited approval–one that requires patients to first use its existing blockbuster, ipi. Folks should keep this in mind in developing their treatment plan in the coming months as being “ipi naive” may be an obstacle to receiving anti-PD-1 even after it is approved and available.
-How can Merck file with the Food and Drug Administration for its programmed cell death receptor 1 (PD-1) drug, MK-3475 for melanoma before rival Bristol-Myers Squibb BMY +0.61%, which has presented more advanced data on its similar drug? Perlmutter says he won’t commment on Bristol’s data, but that MK-3475′s “breakthrough designation” helped speed communication with the FDA. The agency was willing to consider approve the drug because it shrinks tumors, without survival data, only if there’s a population of patients who have no other options. In this case, the FDA will view an application for MK-3475 in patients with advanced melanoma who have failed Bristol’s Yervoy. There’s about 9,000 patients with disease that advanced, and Yervoy helps about 10% of them, he says.February 18, 2014 at 11:25 pm #63586
I wish I knew the answer, I don’t know what the EAP will stipulate. Hopefully it will be nice and easy! But I do dream. I imagine it will probably depend on progression of disease and prior therapies. But there isn’t much info out there to share yet. Stay tuned to clinicaltrials.gov and here for further updates. I don’t know what happened with Amy either. Hopefully she will post. Thanks for keeping up with things and your compassion for others is amazing James.February 19, 2014 at 8:26 pm #63587erinmay22Participant This would be great news! So many folks that would like the chance to try this drug…
ErinFebruary 20, 2014 at 1:40 am #63588Andy123Participant
BMS just posted a pd-1/nivolumab trial ( which looks like expanded access program) for lung cancer this week : http://www.clinicaltrials.gov/ct2/show/NCT02066636?term=Nivolumab&rank=14
So I hope a similar EAP for melanoma is not far.
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