GSK Drug Combo Fast-Tracked
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GSK Drug Combo Fast-Tracked

› Forums › Cutaneous Melanoma Community › GSK Drug Combo Fast-Tracked

  • This topic has 18 replies, 5 voices, and was last updated 12 years ago by POW.
  • Post
    • September 16, 2013 at 2:31 pm
    mrf
    Keymaster

      The GSK combination of a BRAF inhibitor and MEK inhibitor has been granted priority review by the FDA: http://uk.reuters.com/article/2013/09/16/uk-gsk-cancer-drug-combination-gets-us-p-idUKBRE98F06M20130916

      The review is scheduled by January.

      What does this mean?  About half of people with melanoma have tumors with a mutation in BRAF, a critical step in a series of signals that transmit information from the cell wall to the cell nucleus.  In these mutations the BRAF signal is stuck in the "on" position, causing the cell to grow and divide out of control.

      Genentech put a drug on the market in 2011 (vemurafenib, Zelboraf, or "Z") that shuts down the BRAF signal.  It works very quickly and very well, but typically only for a few months.  GSK developed their own BRAF inhibitor (dabrafenib or Tafinlar), but also tested the drug in combination with another drug that blocks MEK (trametinib or Mekinist) the next step in the signaling pathway.  The thinking is that by blocking both BRAF and MEK you can impede the cell's ability to become resistant to the drug.

      Despite the data being very strong, GSK applied for approval of their BRAF and MEK inhibitors as single agents.  Prescribing them in combination would be considered off label and might not be covered by insurance.  Now they have gone back to the FDA asking for approval of the combination.  The FDA has said the data are sufficiently strong that the should fast-track the review and get it approved as quickly as possible.

      This means that a better treatment will be more readily available for patients.  It is also another indication of the importance of combinations.  The MRF has been pushing for more combination studies for years, and even created a special Consortium to facilitate combination trials.

      Tim–MRF

    Viewing 2 reply threads
    • Replies
        • September 16, 2013 at 6:31 pm
        JoshF
        Participant

          Tim-

           

          This is always good news. Can you share insight at to what treatments are available for melanoma patients who do not have the BRAF mutation? It seems to me that many of these new treatments require patient to have BRAF mutation.

            • September 16, 2013 at 6:38 pm
            killmel
            Participant

              Tim,

               

              As you know, we are all anxiously waiting for Merck & Bms PD1 to get approval from the FDA.

              Since Merck as a "break through" status with thier PD1 drug, have you heard when/what timeframe the FDA would approve a PD1 drig for MERK or BMS?

              Thank you for keeping us updated.

              • September 16, 2013 at 8:53 pm
              NYKaren
              Participant
                Hi Tim,

                I really don’t get this. This medicine has come to my home via mail order, here in the USA, for 2 months now, and apparently I am not alone. It’s a regular mail order pharmacy similar to MedCo. It’s the full prescribing strength with both drugs included.

                Thanks

                • September 16, 2013 at 8:53 pm
                NYKaren
                Participant
                  Hi Tim,

                  I really don’t get this. This medicine has come to my home via mail order, here in the USA, for 2 months now, and apparently I am not alone. It’s a regular mail order pharmacy similar to MedCo. It’s the full prescribing strength with both drugs included.

                  Thanks

                  • September 16, 2013 at 8:53 pm
                  NYKaren
                  Participant
                    Hi Tim,

                    I really don’t get this. This medicine has come to my home via mail order, here in the USA, for 2 months now, and apparently I am not alone. It’s a regular mail order pharmacy similar to MedCo. It’s the full prescribing strength with both drugs included.

                    Thanks

                    • September 17, 2013 at 6:02 pm
                    aldakota22
                    Participant

                      This is definitely good news .A step in the right direction for drug companies cooperateing to find an answer to kicking melanomas butt for good.Beat  the Beast.   Al

                      • September 17, 2013 at 6:02 pm
                      aldakota22
                      Participant

                        This is definitely good news .A step in the right direction for drug companies cooperateing to find an answer to kicking melanomas butt for good.Beat  the Beast.   Al

                        • September 17, 2013 at 6:02 pm
                        aldakota22
                        Participant

                          This is definitely good news .A step in the right direction for drug companies cooperateing to find an answer to kicking melanomas butt for good.Beat  the Beast.   Al

                          • September 17, 2013 at 10:34 pm
                          aldakota22
                          Participant

                            This is definitely good news .A step in the right direction for drug companies cooperateing to find an answer to kicking melanomas butt for good.Beat  the Beast.   Al

                            • September 17, 2013 at 10:47 pm
                            POW
                            Participant

                              Actually, Al, the sticking point for getting FDA approval for drug combinations is that different pharmaceutical companies do NOT cooperate. Dabrafenib (a BRAF inhibitor) and tramentinib (a MEK inhibitor) are both made by Glaxo Smith Kline. 

                              Pharmaceutical companies will not collaborate to sponsor joint clinical trials of two different drugs from two different companies. They won't even cooperate to the extent of sharing DNA sequence data or immunological marker data or cell lines or any information from their large collections of melanoma tumors that they got from patients. 

                              The people like Tim who are trying to find a way to get some cooperation going to benefit the patients have my utmost thanks and respect.  

                              • September 17, 2013 at 10:47 pm
                              POW
                              Participant

                                Actually, Al, the sticking point for getting FDA approval for drug combinations is that different pharmaceutical companies do NOT cooperate. Dabrafenib (a BRAF inhibitor) and tramentinib (a MEK inhibitor) are both made by Glaxo Smith Kline. 

                                Pharmaceutical companies will not collaborate to sponsor joint clinical trials of two different drugs from two different companies. They won't even cooperate to the extent of sharing DNA sequence data or immunological marker data or cell lines or any information from their large collections of melanoma tumors that they got from patients. 

                                The people like Tim who are trying to find a way to get some cooperation going to benefit the patients have my utmost thanks and respect.  

                                • September 17, 2013 at 10:47 pm
                                POW
                                Participant

                                  Actually, Al, the sticking point for getting FDA approval for drug combinations is that different pharmaceutical companies do NOT cooperate. Dabrafenib (a BRAF inhibitor) and tramentinib (a MEK inhibitor) are both made by Glaxo Smith Kline. 

                                  Pharmaceutical companies will not collaborate to sponsor joint clinical trials of two different drugs from two different companies. They won't even cooperate to the extent of sharing DNA sequence data or immunological marker data or cell lines or any information from their large collections of melanoma tumors that they got from patients. 

                                  The people like Tim who are trying to find a way to get some cooperation going to benefit the patients have my utmost thanks and respect.  

                                  • September 17, 2013 at 10:34 pm
                                  aldakota22
                                  Participant

                                    This is definitely good news .A step in the right direction for drug companies cooperateing to find an answer to kicking melanomas butt for good.Beat  the Beast.   Al

                                    • September 17, 2013 at 10:34 pm
                                    aldakota22
                                    Participant

                                      This is definitely good news .A step in the right direction for drug companies cooperateing to find an answer to kicking melanomas butt for good.Beat  the Beast.   Al

                                      • September 16, 2013 at 6:38 pm
                                      killmel
                                      Participant

                                        Tim,

                                         

                                        As you know, we are all anxiously waiting for Merck & Bms PD1 to get approval from the FDA.

                                        Since Merck as a "break through" status with thier PD1 drug, have you heard when/what timeframe the FDA would approve a PD1 drig for MERK or BMS?

                                        Thank you for keeping us updated.

                                        • September 16, 2013 at 6:38 pm
                                        killmel
                                        Participant

                                          Tim,

                                           

                                          As you know, we are all anxiously waiting for Merck & Bms PD1 to get approval from the FDA.

                                          Since Merck as a "break through" status with thier PD1 drug, have you heard when/what timeframe the FDA would approve a PD1 drig for MERK or BMS?

                                          Thank you for keeping us updated.

                                        • September 16, 2013 at 6:31 pm
                                        JoshF
                                        Participant

                                          Tim-

                                           

                                          This is always good news. Can you share insight at to what treatments are available for melanoma patients who do not have the BRAF mutation? It seems to me that many of these new treatments require patient to have BRAF mutation.

                                          • September 16, 2013 at 6:31 pm
                                          JoshF
                                          Participant

                                            Tim-

                                             

                                            This is always good news. Can you share insight at to what treatments are available for melanoma patients who do not have the BRAF mutation? It seems to me that many of these new treatments require patient to have BRAF mutation.

                                        Viewing 2 reply threads

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