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What Is The FDA’s Fast Track Designation & How Does It Work?

Home/What Is The FDA’s Fast Track Designation & How Does It Work?

What Is The FDA’s Fast Track Designation & How Does It Work?

Last month I broke a story about the new, experimental anti-myeloma novel therapy agent, carfilzomib:
This Just In: FDA Announces Fast Track Designation For Carfilzomib.

I asked Nadia Hasan, a representative from the manufacturer of carfilzomib, Onyx Pharmaceuticals, to better explain the FDA’s fast track designation process.  She responded by email:

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 an unmet medical need. Myeloma is a good example of a disease with a remaining unmet medical need since the disease eventually becomes refractory to all available treatment options, and people with myeloma need new treatment options.

Through the Fast Track designation, Onyx is eligible to submit the carfilzomib NDA on a rolling basis, allowing Onyx to begin the NDA filing process immediately and giving the FDA an opportunity to review the completed sections of the registration application. Onyx hopes that with the designation, the review and potential approval of carfilzomib could occur more quickly than under normal FDA review timelines.

The next step in the process is for Onyx to complete and submit the remaining sections of the NDA filing, which is expected to occur as early as mid-year.

For more information about FDA Fast Track designation, you can visit:
http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/SpeedingAccesstoImportantNewTherapies/ucm128291.htm#fast

Thanks, Nadia!  Very helpful.
Feel good and keep smiling!  Pat