GSK Drugs
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GSK Drugs

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  • Post
    • 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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