The information on this site is not intended or implied to be a substitute for professional medical advice, diagnosis or treatment. Content within the patient forum is user-generated and has not been reviewed by medical professionals. Other sections of the Melanoma Research Foundation website include information that has been reviewed by medical professionals as appropriate. All medical decisions should be made in consultation with your doctor or other qualified medical professional.

Anti-PD1 to FDA by June

Forums General Melanoma Community Anti-PD1 to FDA by June

  • Post
    POW
    Participant

      Catherine Poole of the Melanoma International Foundation just posted this message

      "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"

      Other posts in that tread talk more about a possible Expanded Access Program (EAP or "compassionate use") and whether or not one needs to try and fail ipi before getting the anti-PD1. You can read the whole thread here:

      http://forum.melanomainternational.org/mif/viewtopic.php?f=54&t=34823 

       

    Viewing 2 reply threads
    • Replies
        JC
        Participant

          is this considered a "cure?"

          JC
          Participant

            is this considered a "cure?"

            JC
            Participant

              is this considered a "cure?"

                killmel
                Participant

                  POW…there was further explaination by MattR (see link below) that if approved, a person would FIRST have to have PROGRESSED on IPI before getting PD1.

                  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.

                  POW
                  Participant

                    Yes, needing to fail ipi before getting anti-PD1 is a rumor that has been circulating for a long time now. However, in response to Mat's comment (quoted above) Catherine Poole said that nobody knows what the final requirements will be for participation in an Expanded Access Program (assuming that Merck starts one). We will just have to wait and see.

                    Mat
                    Participant

                      I'm MathewR–aka Mat.  I don't think that it is a rumor when it is coming direct from MRK in public comments (my comment pertains to approval, not expanded access).  As for my comment on BMS, yes, that's total speculation by me–not based on anything I've read.

                      Mat
                      Participant

                        I'm MathewR–aka Mat.  I don't think that it is a rumor when it is coming direct from MRK in public comments (my comment pertains to approval, not expanded access).  As for my comment on BMS, yes, that's total speculation by me–not based on anything I've read.

                        Mat
                        Participant

                          I'm MathewR–aka Mat.  I don't think that it is a rumor when it is coming direct from MRK in public comments (my comment pertains to approval, not expanded access).  As for my comment on BMS, yes, that's total speculation by me–not based on anything I've read.

                          POW
                          Participant

                            Thank you for the clarification, Mat. That will make it even more interesting to see how things play out with Merck and the FDA over anti-PD1. And I do sympathize with Merck's dilemma in having invested hundreds of millions of dollars in ipi only to compete themselves out of the market with anti-PD1.

                            I have never heard of a case where the FDA approved a drug and required that it only be prescribed after another lesser drug has been tried and failed. Insurance companies may do that with generic versus named drugs, but the FDA??!! And how are physicians going to respond if they are required to prescribe a treatment that is known to be less effective and with more side effects before they will be "allowed" to prescribe the "good stuff"?!

                            I know that graft and corruption are a large and growing problem in our healthcare system, but this level of favoritism is going to to take the cake! 

                            POW
                            Participant

                              Thank you for the clarification, Mat. That will make it even more interesting to see how things play out with Merck and the FDA over anti-PD1. And I do sympathize with Merck's dilemma in having invested hundreds of millions of dollars in ipi only to compete themselves out of the market with anti-PD1.

                              I have never heard of a case where the FDA approved a drug and required that it only be prescribed after another lesser drug has been tried and failed. Insurance companies may do that with generic versus named drugs, but the FDA??!! And how are physicians going to respond if they are required to prescribe a treatment that is known to be less effective and with more side effects before they will be "allowed" to prescribe the "good stuff"?!

                              I know that graft and corruption are a large and growing problem in our healthcare system, but this level of favoritism is going to to take the cake! 

                              Brent Morris
                              Participant

                                It is not Merck's dilemma but that of BMS.IPI is a BMS product as is Nivolumab. All prescribing physicians know of many instances in which "step therapy" requires what is considered a less effective drug prior to another considered more effective.The FDA can impose that as well as insurance companies. Cost also plays a role. Unfortunately this is common. Those who actually work in the medical field are familiar with this . It is not corrupttion but bureaucracy.. Finally I dont care if BMS or Merck put in "millions". They are looking to make "billions".

                                Brent Morris
                                Participant

                                  It is not Merck's dilemma but that of BMS.IPI is a BMS product as is Nivolumab. All prescribing physicians know of many instances in which "step therapy" requires what is considered a less effective drug prior to another considered more effective.The FDA can impose that as well as insurance companies. Cost also plays a role. Unfortunately this is common. Those who actually work in the medical field are familiar with this . It is not corrupttion but bureaucracy.. Finally I dont care if BMS or Merck put in "millions". They are looking to make "billions".

                                  G-Samsa
                                  Participant

                                    The BMS dilemma may not be problematic at all.  The combined Ipi/Nivo therapy, if found to be more effective than anti-pd1 alone will give BMS the leg up on this approach.  I haven't seen any trials that combine the Merck product with IPI… Therefore BMS should have a monopoly on the  the combined therapy.for a time.

                                    G-Samsa
                                    Participant

                                      The BMS dilemma may not be problematic at all.  The combined Ipi/Nivo therapy, if found to be more effective than anti-pd1 alone will give BMS the leg up on this approach.  I haven't seen any trials that combine the Merck product with IPI… Therefore BMS should have a monopoly on the  the combined therapy.for a time.

                                      G-Samsa
                                      Participant

                                        The BMS dilemma may not be problematic at all.  The combined Ipi/Nivo therapy, if found to be more effective than anti-pd1 alone will give BMS the leg up on this approach.  I haven't seen any trials that combine the Merck product with IPI… Therefore BMS should have a monopoly on the  the combined therapy.for a time.

                                        Brent Morris
                                        Participant

                                          It is not Merck's dilemma but that of BMS.IPI is a BMS product as is Nivolumab. All prescribing physicians know of many instances in which "step therapy" requires what is considered a less effective drug prior to another considered more effective.The FDA can impose that as well as insurance companies. Cost also plays a role. Unfortunately this is common. Those who actually work in the medical field are familiar with this . It is not corrupttion but bureaucracy.. Finally I dont care if BMS or Merck put in "millions". They are looking to make "billions".

                                          POW
                                          Participant

                                            Thank you for the clarification, Mat. That will make it even more interesting to see how things play out with Merck and the FDA over anti-PD1. And I do sympathize with Merck's dilemma in having invested hundreds of millions of dollars in ipi only to compete themselves out of the market with anti-PD1.

                                            I have never heard of a case where the FDA approved a drug and required that it only be prescribed after another lesser drug has been tried and failed. Insurance companies may do that with generic versus named drugs, but the FDA??!! And how are physicians going to respond if they are required to prescribe a treatment that is known to be less effective and with more side effects before they will be "allowed" to prescribe the "good stuff"?!

                                            I know that graft and corruption are a large and growing problem in our healthcare system, but this level of favoritism is going to to take the cake! 

                                            POW
                                            Participant

                                              Yes, needing to fail ipi before getting anti-PD1 is a rumor that has been circulating for a long time now. However, in response to Mat's comment (quoted above) Catherine Poole said that nobody knows what the final requirements will be for participation in an Expanded Access Program (assuming that Merck starts one). We will just have to wait and see.

                                              POW
                                              Participant

                                                Yes, needing to fail ipi before getting anti-PD1 is a rumor that has been circulating for a long time now. However, in response to Mat's comment (quoted above) Catherine Poole said that nobody knows what the final requirements will be for participation in an Expanded Access Program (assuming that Merck starts one). We will just have to wait and see.

                                                killmel
                                                Participant

                                                  POW…there was further explaination by MattR (see link below) that if approved, a person would FIRST have to have PROGRESSED on IPI before getting PD1.

                                                  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.

                                                  killmel
                                                  Participant

                                                    POW…there was further explaination by MattR (see link below) that if approved, a person would FIRST have to have PROGRESSED on IPI before getting PD1.

                                                    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.

                                              Viewing 2 reply threads
                                              • You must be logged in to reply to this topic.
                                              About the MRF Patient Forum

                                              The MRF Patient Forum is the oldest and largest online community of people affected by melanoma. It is designed to provide peer support and information to caregivers, patients, family and friends. There is no better place to discuss different parts of your journey with this cancer and find the friends and support resources to make that journey more bearable.

                                              The information on the forum is open and accessible to everyone. To add a new topic or to post a reply, you must be a registered user. Please note that you will be able to post both topics and replies anonymously even though you are logged in. All posts must abide by MRF posting policies.