GSK Drugs

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    • July 9, 2013 at 1:50 pm
    mrf
    Keymaster

      GSK just submitted an application to the FDA for their two new melanoma drugs to be used in combination.  This is a BRAF inhibitor, dabrafenib, and a MEK inhibitor, trametinib.  Studies have shown that these drugs work better in combination than either do alone.  I think most people expected they would be prescribed in combination, but getting this approval, if it is approved, will help smooth conversations about off-label usage and reimbursement.

      GSK just submitted an application to the FDA for their two new melanoma drugs to be used in combination.  This is a BRAF inhibitor, dabrafenib, and a MEK inhibitor, trametinib.  Studies have shown that these drugs work better in combination than either do alone.  I think most people expected they would be prescribed in combination, but getting this approval, if it is approved, will help smooth conversations about off-label usage and reimbursement.

      http://www.gsk.com/media/press-releases/2013/GSK-announces-US-submission-for-dabrafenib-trametinib-combination-in-metastatic-melanoma.htmlTim–MRF

      Tim–MRF

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    • Replies
        • July 9, 2013 at 2:35 pm
        POW
        Participant

          That is teriffic news, Tim! Thank you! 

          Is there anything we can do to assist or speed the approval process? Write to the FDA? Check with our insurance companies to find out if they will pay for the simulatneous administration of both drugs if the combo is NOT FDA approved? (A strong inducement to approve the combo, in my opinion.) Anything?

          • July 9, 2013 at 2:35 pm
          POW
          Participant

            That is teriffic news, Tim! Thank you! 

            Is there anything we can do to assist or speed the approval process? Write to the FDA? Check with our insurance companies to find out if they will pay for the simulatneous administration of both drugs if the combo is NOT FDA approved? (A strong inducement to approve the combo, in my opinion.) Anything?

            • July 9, 2013 at 2:35 pm
            POW
            Participant

              That is teriffic news, Tim! Thank you! 

              Is there anything we can do to assist or speed the approval process? Write to the FDA? Check with our insurance companies to find out if they will pay for the simulatneous administration of both drugs if the combo is NOT FDA approved? (A strong inducement to approve the combo, in my opinion.) Anything?

              • July 9, 2013 at 4:27 pm
              Tim–MRF
              Guest

                Good question.  I think in this case it is a slam dunk–the data is pretty clear.  Let's hold off the letter writing for something that might need a push, such as some of the PD-1 issues we are likely to face in the next months.

                Tim–MRF

                • July 9, 2013 at 4:27 pm
                Tim–MRF
                Guest

                  Good question.  I think in this case it is a slam dunk–the data is pretty clear.  Let's hold off the letter writing for something that might need a push, such as some of the PD-1 issues we are likely to face in the next months.

                  Tim–MRF

                  • July 9, 2013 at 4:27 pm
                  Tim–MRF
                  Guest

                    Good question.  I think in this case it is a slam dunk–the data is pretty clear.  Let's hold off the letter writing for something that might need a push, such as some of the PD-1 issues we are likely to face in the next months.

                    Tim–MRF

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