For Tim-MRF PD1 Question

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    • June 4, 2013 at 8:18 pm
    killmel
    Participant

      Hi Tim,

       

      Thank you so much for keeping us updated  at Asco.

       

      The news regarding anti-PD1 for BMS & Merck was very encouraging.

       

      Based on input at Asco & your many years with MRF, what is your best guess when you think that FDA will realistically approve anti-PD1. If you were a betting man, which pharaceutical company do you think will get approval first?

       

      Thanks for helping all of us.

       

       

      Hi Tim,

       

      Thank you so much for keeping us updated  at Asco.

       

      The news regarding anti-PD1 for BMS & Merck was very encouraging.

       

      Based on input at Asco & your many years with MRF, what is your best guess when you think that FDA will realistically approve anti-PD1. If you were a betting man, which pharaceutical company do you think will get approval first?

       

      Thanks for helping all of us.

       

       

    Viewing 2 reply threads
    • Replies
        • June 5, 2013 at 8:32 pm
        Tim–MRF
        Guest

          These are great questions, and I don't know that anyone knows the answer.

          I think the Merck PD-1 may be approved first.  Some researchers argue that we already have enough data to approve the drug.  I don't know that this is the thinking of the FDA, but I do know that the FDA is interested in moving things forward more quickly.

          Some researchers have argued that the combination of ipi (a BMS drug) with the BMS anti-PD-1, "nivo" should be approved based on a single-arm Phase II study. 

          So, if I had a crystal ball, I would guess that one of the anti-PD1 drugs will be approved no sooner than six months from now but no longer than 12 months from now.  I would guess the combination would be 18 months to 24 months from now.

          In the meantime, both BMS and Merck are opening a lot of slots.  The ipi/nivo combo is going into Phase III studies.

          Big question is how aggressive Genentech/Roche will be with their anti PD-L-1 in melanoma.  They like this drug a lot, but it is showing impact in several different cancers.

          Tim–MRF

          • June 5, 2013 at 8:32 pm
          Tim–MRF
          Guest

            These are great questions, and I don't know that anyone knows the answer.

            I think the Merck PD-1 may be approved first.  Some researchers argue that we already have enough data to approve the drug.  I don't know that this is the thinking of the FDA, but I do know that the FDA is interested in moving things forward more quickly.

            Some researchers have argued that the combination of ipi (a BMS drug) with the BMS anti-PD-1, "nivo" should be approved based on a single-arm Phase II study. 

            So, if I had a crystal ball, I would guess that one of the anti-PD1 drugs will be approved no sooner than six months from now but no longer than 12 months from now.  I would guess the combination would be 18 months to 24 months from now.

            In the meantime, both BMS and Merck are opening a lot of slots.  The ipi/nivo combo is going into Phase III studies.

            Big question is how aggressive Genentech/Roche will be with their anti PD-L-1 in melanoma.  They like this drug a lot, but it is showing impact in several different cancers.

            Tim–MRF

            • June 5, 2013 at 8:32 pm
            Tim–MRF
            Guest

              These are great questions, and I don't know that anyone knows the answer.

              I think the Merck PD-1 may be approved first.  Some researchers argue that we already have enough data to approve the drug.  I don't know that this is the thinking of the FDA, but I do know that the FDA is interested in moving things forward more quickly.

              Some researchers have argued that the combination of ipi (a BMS drug) with the BMS anti-PD-1, "nivo" should be approved based on a single-arm Phase II study. 

              So, if I had a crystal ball, I would guess that one of the anti-PD1 drugs will be approved no sooner than six months from now but no longer than 12 months from now.  I would guess the combination would be 18 months to 24 months from now.

              In the meantime, both BMS and Merck are opening a lot of slots.  The ipi/nivo combo is going into Phase III studies.

              Big question is how aggressive Genentech/Roche will be with their anti PD-L-1 in melanoma.  They like this drug a lot, but it is showing impact in several different cancers.

              Tim–MRF

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