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This Just In: FDA Announces Fast Track Designation For Carfilzomib

Home/This Just In: FDA Announces Fast Track Designation For Carfilzomib

This Just In: FDA Announces Fast Track Designation For Carfilzomib

I wanted to share this wonderful news right away…
Here is an e-mail I received from a contact who works closely with Onyx Pharmaceuticals, Nadia Hasan:

Dear Pat,

On behalf of Onyx Pharmaceuticals, I am pleased to share with you the attached press release announcing that today the U.S. Food and Drug Administration (FDA) has granted fast track designation for carfilzomib, a next generation proteasome inhibitor for the potential treatment of patients with relapsed and refractory multiple myeloma. The Fast Track designation process was developed by the FDA to facilitate the development, and expedite the review of drugs to treat serious or life-threatening diseases and address unmet medical needs.

Positive complete results from the Phase 2b 003-A1 study evaluating single-agent carfilzomib in patients with relapsed and refractory multiple myeloma were recently announced at the American Society of Hematology (ASH) meeting in December 2010.

Please let me know if you have any questions.  Thank you for your commitment to patients with multiple myeloma!

Best regards,
Nadia
 
Wow!  Sounds like carfilzomib is back “on track!”  (Pun intended!)  You can read today’s press release–in its entirety–by going to MyelomaNews.com/FDA Announces Fast Track Designation For Carfilzomib.
 
Feel good and keep smiling!  Pat