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Merck scores “breakthrough status” from FDA

Forums General Melanoma Community Merck scores “breakthrough status” from FDA

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      NYKaren
      Participant

        Sounds exciting!

        Does anyone know what this translates to regarding approval time?  

        Karen

          Bubbles
          Participant

            While this is certainly not bad news at all….I fear the reality of this is more of an ad/announcement for Merck seeking financial investors than it is for medical providers or patients.  Just google "lambrolizumab" –  the "name" that Merck has given its anti-PD1 product and you will see that this news is almost exclusively spread in financial/investor journals and articles.  That said, it is still good news for it getting ever closer to FDA approval.  And….given my review of the data….preliminary though it is….and through discussions with my provider…(though Merck's still running behind BMS in data accumulated)….it is looking as though the Merck results might be better than the BMS anti-PD1 that I am taking.  SO….it is still wait and see for those in desperate need of both these therapies.  I think the data to be presented at ASCO in June will be very informative and crucial in getting these drugs approved  and on the market.

            Hang in there.  C

            Bubbles
            Participant

              While this is certainly not bad news at all….I fear the reality of this is more of an ad/announcement for Merck seeking financial investors than it is for medical providers or patients.  Just google "lambrolizumab" –  the "name" that Merck has given its anti-PD1 product and you will see that this news is almost exclusively spread in financial/investor journals and articles.  That said, it is still good news for it getting ever closer to FDA approval.  And….given my review of the data….preliminary though it is….and through discussions with my provider…(though Merck's still running behind BMS in data accumulated)….it is looking as though the Merck results might be better than the BMS anti-PD1 that I am taking.  SO….it is still wait and see for those in desperate need of both these therapies.  I think the data to be presented at ASCO in June will be very informative and crucial in getting these drugs approved  and on the market.

              Hang in there.  C

              Bubbles
              Participant

                While this is certainly not bad news at all….I fear the reality of this is more of an ad/announcement for Merck seeking financial investors than it is for medical providers or patients.  Just google "lambrolizumab" –  the "name" that Merck has given its anti-PD1 product and you will see that this news is almost exclusively spread in financial/investor journals and articles.  That said, it is still good news for it getting ever closer to FDA approval.  And….given my review of the data….preliminary though it is….and through discussions with my provider…(though Merck's still running behind BMS in data accumulated)….it is looking as though the Merck results might be better than the BMS anti-PD1 that I am taking.  SO….it is still wait and see for those in desperate need of both these therapies.  I think the data to be presented at ASCO in June will be very informative and crucial in getting these drugs approved  and on the market.

                Hang in there.  C

                rbruce
                Participant

                  It's a great day in melanomaville!  I've been on MK3475 for a year now and have had awesome results.  I'm happy for Merck that they use this opportunity to seek investors, private enterprise at it's best rather than waiting for government.  As far as approval time, this announcement will help drive people to the trials, they fill faster, more research is completed and faster approval is the result.  My Doc believes approval will be within 2 years and more trials are opening regularly.  

                  rbruce
                  Participant

                    It's a great day in melanomaville!  I've been on MK3475 for a year now and have had awesome results.  I'm happy for Merck that they use this opportunity to seek investors, private enterprise at it's best rather than waiting for government.  As far as approval time, this announcement will help drive people to the trials, they fill faster, more research is completed and faster approval is the result.  My Doc believes approval will be within 2 years and more trials are opening regularly.  

                    rbruce
                    Participant

                      It's a great day in melanomaville!  I've been on MK3475 for a year now and have had awesome results.  I'm happy for Merck that they use this opportunity to seek investors, private enterprise at it's best rather than waiting for government.  As far as approval time, this announcement will help drive people to the trials, they fill faster, more research is completed and faster approval is the result.  My Doc believes approval will be within 2 years and more trials are opening regularly.  

                      LynnLuc
                      Participant

                        I have just finished BMS's Anti PD-1 after 30 months..I have been NED Stage 4 for 3 years…my onc says it will probably be 2 years as well.-They need to do greater population studies first.  Lynn

                        LynnLuc
                        Participant

                          I have just finished BMS's Anti PD-1 after 30 months..I have been NED Stage 4 for 3 years…my onc says it will probably be 2 years as well.-They need to do greater population studies first.  Lynn

                          LynnLuc
                          Participant

                            I have just finished BMS's Anti PD-1 after 30 months..I have been NED Stage 4 for 3 years…my onc says it will probably be 2 years as well.-They need to do greater population studies first.  Lynn

                          NYKaren
                          Participant

                            Sounds exciting!

                            Does anyone know what this translates to regarding approval time?  

                            Karen

                            NYKaren
                            Participant

                              Sounds exciting!

                              Does anyone know what this translates to regarding approval time?  

                              Karen

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