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New Drugs approved by FDA

Forums Ocular Melanoma Community New Drugs approved by FDA

  • Post
    mrf
    Keymaster

      The FDA just approved two new drugs for treating metastatic melanoma.  One is a BRAF inhibitor, similar to Zelboraf (vemurafenib).  The other is a MEK inhibitor.

      The MEK inhibitor can be used in patients whose tumors do not have the BRAF mutation, and also is being tested in uveal melanoma.

      The biggest use, though will likely be in combining the BRAF and MEK inhibitors.  Studies have shown that patients with the BRAF mutation who were treated with the combination had better response, longer response, and fewer side effects. 

      The FDA just approved two new drugs for treating metastatic melanoma.  One is a BRAF inhibitor, similar to Zelboraf (vemurafenib).  The other is a MEK inhibitor.

      The MEK inhibitor can be used in patients whose tumors do not have the BRAF mutation, and also is being tested in uveal melanoma.

      The biggest use, though will likely be in combining the BRAF and MEK inhibitors.  Studies have shown that patients with the BRAF mutation who were treated with the combination had better response, longer response, and fewer side effects. 

      Here is the press release:

      http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm354199.htm

      This is big news for the melanoma community, and a great step forward!  We still have a long way to go, but two new drugs is a good thing.

      Tim–MRF

    Viewing 20 reply threads
    • Replies
        JC
        Participant

          If it delays tumor growth 2-3 months, it's a breakthrough drug?  Am I reading the data wrong?

          JC
          Participant

            If it delays tumor growth 2-3 months, it's a breakthrough drug?  Am I reading the data wrong?

              Tim–MRF
              Guest

                No, you are not reading the data wrong.  This is by no means a magic bullet.  It is another step forward, however, and some group of patients will have longer response times.  When the BRAF and MEK are given together the median response time goes from 6 months for the BRAF alone to close to 11 months.  Again, nothing close to a cure, but a step forward.

                This is the disconnect between excitment over progress, and the harsh reality that the fight is still very, very tough.  I do not mean to diminish the fact that a few extra months is not wonderful.  Not bad, but not wonderful.

                 

                Tim–MRF

                Tim–MRF
                Guest

                  No, you are not reading the data wrong.  This is by no means a magic bullet.  It is another step forward, however, and some group of patients will have longer response times.  When the BRAF and MEK are given together the median response time goes from 6 months for the BRAF alone to close to 11 months.  Again, nothing close to a cure, but a step forward.

                  This is the disconnect between excitment over progress, and the harsh reality that the fight is still very, very tough.  I do not mean to diminish the fact that a few extra months is not wonderful.  Not bad, but not wonderful.

                   

                  Tim–MRF

                  Tim–MRF
                  Guest

                    No, you are not reading the data wrong.  This is by no means a magic bullet.  It is another step forward, however, and some group of patients will have longer response times.  When the BRAF and MEK are given together the median response time goes from 6 months for the BRAF alone to close to 11 months.  Again, nothing close to a cure, but a step forward.

                    This is the disconnect between excitment over progress, and the harsh reality that the fight is still very, very tough.  I do not mean to diminish the fact that a few extra months is not wonderful.  Not bad, but not wonderful.

                     

                    Tim–MRF

                  JC
                  Participant

                    If it delays tumor growth 2-3 months, it's a breakthrough drug?  Am I reading the data wrong?

                    NYKaren
                    Participant
                      It’s a big step forward! This is a happy day & a step in the right direction. Next stop, PD1.
                      NYKaren
                      Participant
                        It’s a big step forward! This is a happy day & a step in the right direction. Next stop, PD1.
                        NYKaren
                        Participant
                          It’s a big step forward! This is a happy day & a step in the right direction. Next stop, PD1.
                          POW
                          Participant

                            Tim, thanks for the great news! That seems to be a rather speedy approval process, especially for the MEK drug. That's wonderful.

                            As for the median duration of response, it seems to me that some small percentage of people (10%? 15$%?) seem to have a very long duration response nto some particular drug. 10%-15% have long term response to radiation or to biochemo. Another 10%-15% have a long response to Zelboraf. Same with Yervoy and now BRAF+MEK–10%-15% of patients will be long-term responders to one of those treatments. 

                            So while it would be great to have a treatment that cures melanoma in everyone, each new "effective" treatment is another arrow in the oncologist's quiver. Any given arrow might just be the one that YOU respond to long-term. So keep them arrows coming, folks! Hooray!!

                            POW
                            Participant

                              Tim, thanks for the great news! That seems to be a rather speedy approval process, especially for the MEK drug. That's wonderful.

                              As for the median duration of response, it seems to me that some small percentage of people (10%? 15$%?) seem to have a very long duration response nto some particular drug. 10%-15% have long term response to radiation or to biochemo. Another 10%-15% have a long response to Zelboraf. Same with Yervoy and now BRAF+MEK–10%-15% of patients will be long-term responders to one of those treatments. 

                              So while it would be great to have a treatment that cures melanoma in everyone, each new "effective" treatment is another arrow in the oncologist's quiver. Any given arrow might just be the one that YOU respond to long-term. So keep them arrows coming, folks! Hooray!!

                              POW
                              Participant

                                Tim, thanks for the great news! That seems to be a rather speedy approval process, especially for the MEK drug. That's wonderful.

                                As for the median duration of response, it seems to me that some small percentage of people (10%? 15$%?) seem to have a very long duration response nto some particular drug. 10%-15% have long term response to radiation or to biochemo. Another 10%-15% have a long response to Zelboraf. Same with Yervoy and now BRAF+MEK–10%-15% of patients will be long-term responders to one of those treatments. 

                                So while it would be great to have a treatment that cures melanoma in everyone, each new "effective" treatment is another arrow in the oncologist's quiver. Any given arrow might just be the one that YOU respond to long-term. So keep them arrows coming, folks! Hooray!!

                                DonnaK
                                Participant

                                  This is fantastic news! Thx for sharing.  Any idea whether either of these drugs cross the BBB?  I know they aren't approved as a combo therapy yet, but can docs prescribe them off-label together?

                                  Donna

                                  DonnaK
                                  Participant

                                    This is fantastic news! Thx for sharing.  Any idea whether either of these drugs cross the BBB?  I know they aren't approved as a combo therapy yet, but can docs prescribe them off-label together?

                                    Donna

                                    DonnaK
                                    Participant

                                      This is fantastic news! Thx for sharing.  Any idea whether either of these drugs cross the BBB?  I know they aren't approved as a combo therapy yet, but can docs prescribe them off-label together?

                                      Donna

                                      SteveH230
                                      Participant
                                        Thanks Tim. The article states “Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.”

                                        They didn’t specifically say that it is approved for BRAF wild-type, but I see that you said that iit can be used for patients without BRAF mutations. is this a mistake or omission on their part in the press release?

                                        I ask because my wife has the NRAS mutation and this would be another option for her if correct. Would appreciate any clarification you can provide. Thanks!

                                        Steve

                                        SteveH230
                                        Participant
                                          Thanks Tim. The article states “Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.”

                                          They didn’t specifically say that it is approved for BRAF wild-type, but I see that you said that iit can be used for patients without BRAF mutations. is this a mistake or omission on their part in the press release?

                                          I ask because my wife has the NRAS mutation and this would be another option for her if correct. Would appreciate any clarification you can provide. Thanks!

                                          Steve

                                            Tim–MRF
                                            Guest

                                              Steve:

                                              The label only specifies the V600 mutation, but MEK has been tested in BRAF wild-type patients and I suspect that it will be used off-label for that patient population as a second or third line therapy.  We will have to wait and see how this plays out.  They are even testing MEK in uveal melanoma patients, and they don't have BRAF mutations or NRAS mutations.

                                              I think that more focus for NRAS patients is being placed on PI3 kinase inhibitors, but will know more after ASCO this weekend.

                                               

                                              Tim–MRF

                                              Tim–MRF
                                              Guest

                                                Steve:

                                                The label only specifies the V600 mutation, but MEK has been tested in BRAF wild-type patients and I suspect that it will be used off-label for that patient population as a second or third line therapy.  We will have to wait and see how this plays out.  They are even testing MEK in uveal melanoma patients, and they don't have BRAF mutations or NRAS mutations.

                                                I think that more focus for NRAS patients is being placed on PI3 kinase inhibitors, but will know more after ASCO this weekend.

                                                 

                                                Tim–MRF

                                                SteveH230
                                                Participant

                                                  Thanks for clarifying, Tim.  We are on 3rd line right now so that's good to hear.  Will be keeping a close eye on ASCO for sure…

                                                  SteveH230
                                                  Participant

                                                    Thanks for clarifying, Tim.  We are on 3rd line right now so that's good to hear.  Will be keeping a close eye on ASCO for sure…

                                                    SteveH230
                                                    Participant

                                                      Thanks for clarifying, Tim.  We are on 3rd line right now so that's good to hear.  Will be keeping a close eye on ASCO for sure…

                                                      Tim–MRF
                                                      Guest

                                                        Steve:

                                                        The label only specifies the V600 mutation, but MEK has been tested in BRAF wild-type patients and I suspect that it will be used off-label for that patient population as a second or third line therapy.  We will have to wait and see how this plays out.  They are even testing MEK in uveal melanoma patients, and they don't have BRAF mutations or NRAS mutations.

                                                        I think that more focus for NRAS patients is being placed on PI3 kinase inhibitors, but will know more after ASCO this weekend.

                                                         

                                                        Tim–MRF

                                                      SteveH230
                                                      Participant
                                                        Thanks Tim. The article states “Mekinist, a MEK inhibitor, is approved to treat patients whose tumors express the BRAF V600E or V600K gene mutations.”

                                                        They didn’t specifically say that it is approved for BRAF wild-type, but I see that you said that iit can be used for patients without BRAF mutations. is this a mistake or omission on their part in the press release?

                                                        I ask because my wife has the NRAS mutation and this would be another option for her if correct. Would appreciate any clarification you can provide. Thanks!

                                                        Steve

                                                        Harry in Fair Oaks
                                                        Participant

                                                          I have been on a combination trial of these two drugs for the past two years.  I agree with Tim that the biggest use will likely be in combining the drugs.  But I have questions:

                                                          Since the drugs are for now approved by the FDA only as single agents, will insurance companies and/or Medicare pay for both drugs when prescribed in combination? 

                                                          Ethically, doctors are bound to prescribe the combination.  But will insurers refuse to pay the extra $7000 – $8000 a month for the second drug?

                                                          Harry in Fair Oaks
                                                          Participant

                                                            I have been on a combination trial of these two drugs for the past two years.  I agree with Tim that the biggest use will likely be in combining the drugs.  But I have questions:

                                                            Since the drugs are for now approved by the FDA only as single agents, will insurance companies and/or Medicare pay for both drugs when prescribed in combination? 

                                                            Ethically, doctors are bound to prescribe the combination.  But will insurers refuse to pay the extra $7000 – $8000 a month for the second drug?

                                                            Harry in Fair Oaks
                                                            Participant

                                                              I have been on a combination trial of these two drugs for the past two years.  I agree with Tim that the biggest use will likely be in combining the drugs.  But I have questions:

                                                              Since the drugs are for now approved by the FDA only as single agents, will insurance companies and/or Medicare pay for both drugs when prescribed in combination? 

                                                              Ethically, doctors are bound to prescribe the combination.  But will insurers refuse to pay the extra $7000 – $8000 a month for the second drug?

                                                                POW
                                                                Participant

                                                                  No, Harry, doctors are not "ethically bound" to prescribe the combination. My brother's doctor, for example, refused to prescibe anything off-label because if it didn't have FDA approval, it MIGHT have unexpected adverse effects. I'm still not sure if that was his personal philosophy or the VA's policy. 

                                                                  Nevertheless, the point people are making about insurance refusing to pay for BRAF and MEK at the same time is well taken and is a source of real concern. Catherine Poole at MIF says that the FDA will soon approve the combination, but who knows when? The other avenue is to get Medicare to approve paying for both at once– most (not all) insurance companies will eventually follow Mediare's lead. 

                                                                  And so the battle continues…

                                                                  POW
                                                                  Participant

                                                                    No, Harry, doctors are not "ethically bound" to prescribe the combination. My brother's doctor, for example, refused to prescibe anything off-label because if it didn't have FDA approval, it MIGHT have unexpected adverse effects. I'm still not sure if that was his personal philosophy or the VA's policy. 

                                                                    Nevertheless, the point people are making about insurance refusing to pay for BRAF and MEK at the same time is well taken and is a source of real concern. Catherine Poole at MIF says that the FDA will soon approve the combination, but who knows when? The other avenue is to get Medicare to approve paying for both at once– most (not all) insurance companies will eventually follow Mediare's lead. 

                                                                    And so the battle continues…

                                                                    Harry in Fair Oaks
                                                                    Participant

                                                                      Perhaps "ethically bound" is too loaded a term.  But I suspect many doctors will prescribe the combination even before the FDA gives specific approval.  I know my oncologist will.

                                                                      Best wishes,

                                                                      Harry

                                                                      Harry in Fair Oaks
                                                                      Participant

                                                                        Perhaps "ethically bound" is too loaded a term.  But I suspect many doctors will prescribe the combination even before the FDA gives specific approval.  I know my oncologist will.

                                                                        Best wishes,

                                                                        Harry

                                                                        Harry in Fair Oaks
                                                                        Participant

                                                                          Perhaps "ethically bound" is too loaded a term.  But I suspect many doctors will prescribe the combination even before the FDA gives specific approval.  I know my oncologist will.

                                                                          Best wishes,

                                                                          Harry

                                                                          POW
                                                                          Participant

                                                                            No, Harry, doctors are not "ethically bound" to prescribe the combination. My brother's doctor, for example, refused to prescibe anything off-label because if it didn't have FDA approval, it MIGHT have unexpected adverse effects. I'm still not sure if that was his personal philosophy or the VA's policy. 

                                                                            Nevertheless, the point people are making about insurance refusing to pay for BRAF and MEK at the same time is well taken and is a source of real concern. Catherine Poole at MIF says that the FDA will soon approve the combination, but who knows when? The other avenue is to get Medicare to approve paying for both at once– most (not all) insurance companies will eventually follow Mediare's lead. 

                                                                            And so the battle continues…

                                                                          out4air
                                                                          Participant
                                                                            GREAT NEWS!
                                                                            out4air
                                                                            Participant
                                                                              GREAT NEWS!
                                                                              out4air
                                                                              Participant
                                                                                GREAT NEWS!
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