Karen's Question about GSK drugs

Posted By
Tim--MRF
4/9/2013 10:48am
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Replies: 4

I have been on the road a lot and am a bit behind on posts with MPIP.  Karen, thank you for flagging your post about the new GSK drugs.

GSK has two drugs for melanoma--one is a BRAF inhibitor like Zelboraf (vemurafenib).  The other blocks the next step down in the MAP kinase pathway--MEK.  The data is complete on these drugs and the FDA is currently reviewing the data.  They have announced June 3 as the PDUFA date on these drugs, or the date by which the FDA response to the application will be made.  Sometimes the PDUFA date is pushed back, as happened with Yervoy (ipi) but this is rather unusual.  More likely the June 3 date will hold, or something will be announced early.

The BRAF drug, dabrafenib, will only be available to people whose tumor has the BRAF mutation.  The MEK inhibitor, trametenib, will likely be used for people who are BRAF wild type but have the NRAS mutation, and may be used more broadly than that.

The best thing about this is that with an approved MEK inhibitor doctors can more readily prescribe the BRAF and MEK drugs on combination.  The data is clear that this is a better approach than a BRAF inhibitor alone.

Since GSK did not apply for approval of the combination it is not clear if payers (insurance companies) will cover the cost of the combination.  This will all need to be worked out, and might be an opportunity for the patient voice to be heard.

By the way, I am in Denver for our bi-annual in-person board meeting.  If you have anything you would like me to convey to our board please send me a note at tturnham@melanoma.org.  We meet this afternoon and tomorrow morning.

Tim--MRF

 

 

Tim, thanks so much for the reply.
I'm looking forward to both drugs being approved, and the insurance coverage questions should prove interesting.
Karen

Don't Stop Believing

Owl - (4/12/2013 - 7:38am)

Dear Tim,

thank you for the explanation. Most of the people here are surely very excited about the approval of these drugs and especially ways to combine both drugs. We live in Germany and hope that the the MEK inhibitor will be approved in Europe as well and the combination will be possible as well. My husband is on Zelboraf almost 4 months now.

One more question, how do you define a "approved MEK inhibitor doctors". Are these doctors that have been involved in the combination trial?

Thanks again,

Jenny

POW - (4/12/2013 - 7:43am)

Hi, Jenny-

There is no such thing as an "approved MEK inhibitor doctor". Perhaps inserting a comma between the two phrases in the sentence would clarify the meaning. Like this: ...'with an approved MEK inhibitor, doctors can...'

Hello, Thank you for the excellent update!  We are awaiting these drugs-to treat brain mets!  Timing is critical - as always in a rush for time.

Thanks again- I will share with the family.

All the best

MrsMarilyn

(sister of Gary stage IV for 11 years)