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PLX 4032 (Zelboraf)
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PLX 4032 (Zelboraf)

› Forums › General Melanoma Community › PLX 4032 (Zelboraf)

  • Post
    • August 17, 2011 at 1:51 pm
    mrf
    Keymaster

      The FDA approved the Plexxikon/Roche/Genentech BRAF inhibitor this morning, months before when they had to do so.  This is a great breakthrough in a number of ways:

      –two drugs approved in one year after 13 years of nothing being approved

      –approval of "targeted therapy", a different way of attacking melanoma than anything else that has been approved

      –rapid approval by the FDA

      The FDA approved the Plexxikon/Roche/Genentech BRAF inhibitor this morning, months before when they had to do so.  This is a great breakthrough in a number of ways:

      –two drugs approved in one year after 13 years of nothing being approved

      –approval of "targeted therapy", a different way of attacking melanoma than anything else that has been approved

      –rapid approval by the FDA

      All indications are that more drugs will be in the pipeline for approval in the next few years, so the field truly is changing.  This all has a long way yet to go, but progress is so very much better than no progress!

      Tim–MRF

       

    Viewing 9 reply threads
    • Replies
        • August 17, 2011 at 2:22 pm
        DeniseK
        Participant

          This is such awesome news!  I've heard great things about the PLX 4032!! 

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

            This is such awesome news!  I've heard great things about the PLX 4032!! 

            • August 17, 2011 at 5:04 pm
            dutchhook
            Participant

              Thanks Tim for posting. We are on the compassionate use study and were immediately concerned about my wife's treatment. Sounds like we'll be ok if our insurance picks it up. We did agree to be contacted by reporters on the drug as was requested last week on the MRF site.

              We already got one phone call from a reporter today I guess. We're very thankful of the people who developed the drug and the doctors who got us into the study because without them, my wife might not be here today!

              Steve & Teri

              • August 17, 2011 at 5:04 pm
              dutchhook
              Participant

                Thanks Tim for posting. We are on the compassionate use study and were immediately concerned about my wife's treatment. Sounds like we'll be ok if our insurance picks it up. We did agree to be contacted by reporters on the drug as was requested last week on the MRF site.

                We already got one phone call from a reporter today I guess. We're very thankful of the people who developed the drug and the doctors who got us into the study because without them, my wife might not be here today!

                Steve & Teri

                • August 17, 2011 at 7:53 pm
                MariaH
                Participant

                  Thank you for sharing the news Tim.  I hope this will open more doorways for researchers looking into other mutations as well for the 46-60% that don't have the B-RAF.  A stepping stone for sure, but I hope that they are looking towards building a complete bridge over water!

                  • August 17, 2011 at 7:53 pm
                  MariaH
                  Participant

                    Thank you for sharing the news Tim.  I hope this will open more doorways for researchers looking into other mutations as well for the 46-60% that don't have the B-RAF.  A stepping stone for sure, but I hope that they are looking towards building a complete bridge over water!

                    • August 18, 2011 at 1:03 am
                    Charlie S
                    Participant

                      Good to see, but what a dumb ass drug name.

                      You will not say it, but I will

                      Charlie S

                        • August 18, 2011 at 1:22 am
                        JerryfromFauq
                        Participant

                          Any thoughts on how the name was developed?

                          Z (the)

                          e (from V600E)  (perhaps el froom mel?)

                          l

                          b (braf)

                          o (only)

                          raf

                          ???

                          • August 18, 2011 at 1:22 am
                          JerryfromFauq
                          Participant

                            Any thoughts on how the name was developed?

                            Z (the)

                            e (from V600E)  (perhaps el froom mel?)

                            l

                            b (braf)

                            o (only)

                            raf

                            ???

                            • August 18, 2011 at 3:26 am
                            dutchhook
                            Participant

                              Yep, kinda funny. Doesn't even sound batter backwards Faroblez?

                              • August 18, 2011 at 3:26 am
                              dutchhook
                              Participant

                                Yep, kinda funny. Doesn't even sound batter backwards Faroblez?

                              • August 18, 2011 at 1:03 am
                              Charlie S
                              Participant

                                Good to see, but what a dumb ass drug name.

                                You will not say it, but I will

                                Charlie S

                                • August 18, 2011 at 5:09 am
                                shellebrownies
                                Participant

                                  What does this mean for people who are signed up for the compassionate use trial? Are they going to be dropped from it, or if they are already signed up, will that continue? This is quite important to me; my husband is supposed to be starting the trial on Monday.

                                  Thanks.

                                  Michelle, wife of Don

                                    • August 19, 2011 at 2:16 pm
                                    dutchhook
                                    Participant

                                      Every case might be different, but we have been in compassionate use for about 45 days. Just got our second batch of zelboraf. We called to see if we still have to go to chicago every 28 days. They said to come back down at least one more time and that we'd get one more 28 day supply for sure, then sounds like our insurance will have to cover from there.

                                      • August 19, 2011 at 2:16 pm
                                      dutchhook
                                      Participant

                                        Every case might be different, but we have been in compassionate use for about 45 days. Just got our second batch of zelboraf. We called to see if we still have to go to chicago every 28 days. They said to come back down at least one more time and that we'd get one more 28 day supply for sure, then sounds like our insurance will have to cover from there.

                                      • August 18, 2011 at 5:09 am
                                      shellebrownies
                                      Participant

                                        What does this mean for people who are signed up for the compassionate use trial? Are they going to be dropped from it, or if they are already signed up, will that continue? This is quite important to me; my husband is supposed to be starting the trial on Monday.

                                        Thanks.

                                        Michelle, wife of Don

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