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Anti PD1 approval date?

Forums General Melanoma Community Anti PD1 approval date?

  • Post
    jag
    Participant

      does anybody have an idea as to how far along in the trial process PD1 antibody is? I.E, when can you get it without a trial?

      Regards

    Viewing 5 reply threads
    • Replies
        BrianP
        Participant

          Jag,

          There are two main players in anti PD-1, Merck and BMS.  Merck has just announced an expanded access program for their PD-1 drug.  This means it's available to some patients now at clinical trial centers.  There are some conditions such as the patient must have failed ipi.  You can read more about this program here:

          http://forum.melanomainternational.org/mif/viewtopic.php?f=54&t=34889

          When will PD-1 be available from your local oncologist?  Don't know.  Maybe in 2014 but probably more like 2015 but that's just my opinion.

          BrianP
          Participant

            Jag,

            There are two main players in anti PD-1, Merck and BMS.  Merck has just announced an expanded access program for their PD-1 drug.  This means it's available to some patients now at clinical trial centers.  There are some conditions such as the patient must have failed ipi.  You can read more about this program here:

            http://forum.melanomainternational.org/mif/viewtopic.php?f=54&t=34889

            When will PD-1 be available from your local oncologist?  Don't know.  Maybe in 2014 but probably more like 2015 but that's just my opinion.

            BrianP
            Participant

              Jag,

              There are two main players in anti PD-1, Merck and BMS.  Merck has just announced an expanded access program for their PD-1 drug.  This means it's available to some patients now at clinical trial centers.  There are some conditions such as the patient must have failed ipi.  You can read more about this program here:

              http://forum.melanomainternational.org/mif/viewtopic.php?f=54&t=34889

              When will PD-1 be available from your local oncologist?  Don't know.  Maybe in 2014 but probably more like 2015 but that's just my opinion.

              arthurjedi007
              Participant

                It really depends on which PD1 you are referring to.

                Last I read Merck's PD1 is a rolling approval by cancer type. For melanoma they applied in January 2014 and expect approval in July 2014. Other cancers for it are later. Also they have an extended access program that is getting up and running that is ran in a trial format. The requirements are basically you have failed standard treatments like ipi, and if braf positive zel and taf/mek although some are iffy on the taf/mek requirement. My doc says I have to fail it too but he and I actually think it might be working and will scan in may. You can find more about the eap in older posts plus melanoma international foundation website but that's if you want that trial.

                For BMS PD1 the last I read was late this year. The way I read it they did not do the rolling approval by cancer type like Merck thus the melanoma approval is getting delayed by the other cancer types trials finishing up.

                In my opinion if you are not on a treatment then get in Merck's eap if you can but that's just my opinion.

                Also like another post here said there is Astra Zeneca's PD1 at Sarah Cannon in Nashville but again that is a trial and is fairly strict. Much more strict than Merck's eap. But I've never been in a trial so you could call them and find out.

                arthurjedi007
                Participant

                  It really depends on which PD1 you are referring to.

                  Last I read Merck's PD1 is a rolling approval by cancer type. For melanoma they applied in January 2014 and expect approval in July 2014. Other cancers for it are later. Also they have an extended access program that is getting up and running that is ran in a trial format. The requirements are basically you have failed standard treatments like ipi, and if braf positive zel and taf/mek although some are iffy on the taf/mek requirement. My doc says I have to fail it too but he and I actually think it might be working and will scan in may. You can find more about the eap in older posts plus melanoma international foundation website but that's if you want that trial.

                  For BMS PD1 the last I read was late this year. The way I read it they did not do the rolling approval by cancer type like Merck thus the melanoma approval is getting delayed by the other cancer types trials finishing up.

                  In my opinion if you are not on a treatment then get in Merck's eap if you can but that's just my opinion.

                  Also like another post here said there is Astra Zeneca's PD1 at Sarah Cannon in Nashville but again that is a trial and is fairly strict. Much more strict than Merck's eap. But I've never been in a trial so you could call them and find out.

                  arthurjedi007
                  Participant

                    It really depends on which PD1 you are referring to.

                    Last I read Merck's PD1 is a rolling approval by cancer type. For melanoma they applied in January 2014 and expect approval in July 2014. Other cancers for it are later. Also they have an extended access program that is getting up and running that is ran in a trial format. The requirements are basically you have failed standard treatments like ipi, and if braf positive zel and taf/mek although some are iffy on the taf/mek requirement. My doc says I have to fail it too but he and I actually think it might be working and will scan in may. You can find more about the eap in older posts plus melanoma international foundation website but that's if you want that trial.

                    For BMS PD1 the last I read was late this year. The way I read it they did not do the rolling approval by cancer type like Merck thus the melanoma approval is getting delayed by the other cancer types trials finishing up.

                    In my opinion if you are not on a treatment then get in Merck's eap if you can but that's just my opinion.

                    Also like another post here said there is Astra Zeneca's PD1 at Sarah Cannon in Nashville but again that is a trial and is fairly strict. Much more strict than Merck's eap. But I've never been in a trial so you could call them and find out.

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