PD1 approval and the restrictions

[Catherine Poole]

I wanted this to have its own post although mentioned elsewhere. I have been doing some research on the PD1 approval coming soon (we hope) and how that will look for patients. Merck officials and the FDA are not going to discuss this until the approval happens, but I like to look ahead for those of you who are strategizing what therapy to do when and next.. I know how important this can be. So here is what I am hearing (not seeing in writing) from both parties. Because Pembro (Merck PD1) doesn’t have the robust clinical trial data that IPI has, it must prove in a clinical trial (phase III) that it has a better response rate than IPI. It is currently in this trial, fully accrued moving to provide the data results to the FDA. The current application to the FDA is for Accelerated Approval and that will proceed, but require IPI refractory status (progressed on IPI.) The word is there is no requirement that you fail the BRAF therapies before getting the PD1. Within 6 months, hopefully, the full data will be in and PD1 will be approved as a first line therapy. In the meantime, I would work closely with your doctor to strategize your next therapy if you were banking on this approval of pembro. I have more conversations to come and will keep you posted.

[RJoeyB]

Thank you Catherine for trying to stay on top of this for all of us. One of important lessons I’ve learned on my own journey is the importance of timing and sequencing, not just from a “biological effectiveness” perspective but also navigating the policies of regulatory bodies and insurance, and unfortunately, they’re not always congruous.

[Catherine Poole]

I did verify this with a top doc on our board, so it is accurate. Here’s the thing, if FDA wants to approve it for first line they can. If we, as many of you as possible lobbied them with letters and phone calls they might feel pressured to do so. So get cracking! I’ll try to find out the best person to write, but you might just try your local congress or senator to put pressure on. Or maybe you folks know who is the top chief at FDA?

[mazz75]

Hello Catherine

Since anti pd1 will be first approved in the States. Will European citizens with no other option able to buy the medicine?

Regards

[Catherine Poole]

I don’t know how that will work, but I imagine if you come to the U.S. and become a patient of an oncologist, then you can pay out of pocket for the therapy. It does take longer for approvals in Europe/global locations. Hopefully that will speed up this time.

[RJoeyB]

Catherine Poole wrote:

I did verify this with a top doc on our board, so it is accurate.

My apologies if my response to your original post sounded as if I was questioning the accuracy of your information in any way, that was not my intent. I was only highlighting that growing importance of sequencing and timing and the unfortunate circumstance where what’s best for an individual, in consultation with their medical team, doesn’t always line up with trial eligibility criteria, FDA approvals, insurance coverage, etc.

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