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Zeloraf approval(B-RAF)
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Zeloraf approval(B-RAF)

› Forums › General Melanoma Community › Zeloraf approval(B-RAF)

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      • August 17, 2011 at 2:11 pm
      Tim–MRF
      Guest

        Kellie:

        Good question on the trials.  If you are on a standard clinical trial, it will continue as per the protocol.  If you are receiving the drug as part of the expanded access or compassionate use protocol then things will change.  Those programs will be shut down.

        I have spoken with the company extensively on this issue and they have assured me that no-one on the expanded access protocol will have to go without drug.  They will work with the doctors to ensure patients are covered through normal coverage procedures.  All the doctors involved with the expanded access protocol have been informed of this and have been given specific guidance on how to ensure that no patient is taken off the drug.

        Regarding future trials, both Zeloraf and other BRAF inhibitors will continue to be studied.  The most promising of these studies are those involving combinations of BRAF with other drugs.  Most researchers agree that long-lasting results will likely come through these combination studies.

        Tim–MRF

          • August 17, 2011 at 2:22 pm
          KellieSue
          Participant

            Thanks for responding Tim. That makes me feel better! I'm on a standard clinical trial just using Zelboraf.

            Kellie(from Iowa) Stage IV

            • August 17, 2011 at 2:22 pm
            KellieSue
            Participant

              Thanks for responding Tim. That makes me feel better! I'm on a standard clinical trial just using Zelboraf.

              Kellie(from Iowa) Stage IV

              • August 18, 2011 at 10:46 pm
              boot2aboot
              Participant

                Tim, what would they combo zelboraf with?  i know the GSK braf.mek trial but what else are they doing?

                • August 18, 2011 at 10:46 pm
                boot2aboot
                Participant

                  Tim, what would they combo zelboraf with?  i know the GSK braf.mek trial but what else are they doing?

                • August 17, 2011 at 2:11 pm
                Tim–MRF
                Guest

                  Kellie:

                  Good question on the trials.  If you are on a standard clinical trial, it will continue as per the protocol.  If you are receiving the drug as part of the expanded access or compassionate use protocol then things will change.  Those programs will be shut down.

                  I have spoken with the company extensively on this issue and they have assured me that no-one on the expanded access protocol will have to go without drug.  They will work with the doctors to ensure patients are covered through normal coverage procedures.  All the doctors involved with the expanded access protocol have been informed of this and have been given specific guidance on how to ensure that no patient is taken off the drug.

                  Regarding future trials, both Zeloraf and other BRAF inhibitors will continue to be studied.  The most promising of these studies are those involving combinations of BRAF with other drugs.  Most researchers agree that long-lasting results will likely come through these combination studies.

                  Tim–MRF

                  • August 17, 2011 at 3:23 pm
                  Harry in Fair Oaks
                  Participant

                    Remember that this drug isn't the only BRAF inhibitor in town.  There is also the GlaxoSmithKline version (GSK2118436) which is now in various clinical trials.  I'm on a trial which combines this drug with GSK's MEK inhibitor.

                    Best wishes,

                    Harry

                    • August 17, 2011 at 3:23 pm
                    Harry in Fair Oaks
                    Participant

                      Remember that this drug isn't the only BRAF inhibitor in town.  There is also the GlaxoSmithKline version (GSK2118436) which is now in various clinical trials.  I'm on a trial which combines this drug with GSK's MEK inhibitor.

                      Best wishes,

                      Harry

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