MK-3475 Approval?

Posted By
Anonymous
6/23/2014 9:05am
Activity
Replies: 8

Rumor from a reliable source says MK-3475 (pembrolizumab) could be approved as early as mid summer. 

rosa1 - (6/23/2014 - 10:01am)

Does this source also mention any restrictions, such as prior IPI fail and/or BRAF therapies if BRAF positive?

All things are possible through God!

Anonymous - (6/23/2014 - 10:27am)

He did not give any more info. --- but I research those  questions daily --- I hope the individual oncologist can make that decision.

Anonymous - (6/23/2014 - 10:49am)

Catherine Poole at MIF has been trying to gather information from her contacts about this and put up a post this morning with some information here:

http://forum.melanomainternational.org/mif/viewtopic.php?f=54&t=35124

 

Anonymous - (6/23/2014 - 12:20pm)

On a more favorable note --- When looking at this report, it looks like patients who are  IPI untreated do better that IPI treated patients when given pembrolizumab ----- 

http://www.businesswire.com/news/home/20140602005550/en/Data-Merck%E2%80...

Anonymous - (6/23/2014 - 1:50pm)

Favorable for some, I suppose...

Anonymous - (6/24/2014 - 4:50pm)

How is that favorable if they require you to have IPI before you can get PD1!

Scuba Doc - (6/25/2014 - 7:26am)

Perhaps with all the new test results Merck will allow melanoma patients to take pembrolizumab regardless of having been previously treated with IPI. I know that some patients opted not to take the IPI for other health reasons. Allowing those patients access to pembrolizumab seem like a no brainer based on the current data.

Anonymous - (6/25/2014 - 1:36pm)

It is up to the FDA to decide, be sure to write or call them or your congressman