Peregrine’s lung cancer immunotherapy gets onto FDA fast track

The lead immunotherapy candidate from Peregrine Pharmaceuticals, bavituximab, has been designated by the FDA for fast-tracked appraisal.

Being a potential treatment for an unmet need of a serious, life-threatening condition – non-small cell lung cancer (NSCLC) – the late-stage drug may reach market more quickly because of the designation.

 

“We are very pleased that the FDA has recognised the potential of this novel therapy as a treatment for this serious and devastating type of cancer and look forward to working closely with them to ensure the most efficient review process.”
 
Robert Garnick, head of regulatory affairs, Peregrine Pharmaceuticals.

 

The company recently started its pivotal phase three SUNRISE trial to compare the addition of bavituximab, a monoclonal antibody, to docetaxel versus using the chemotherapy drug alone.

 

pharmaphorum-twitter-page

Related news:

Peregrine Pharma gets FDA fast track designation for immunotherapy bavituximab (NASDAQ).

US FDA grants Peregrine fast track designation for bavituximab in NSCLC (The Pharma Letter).

Reference links:

Peregrine Pharmaceuticals receives FDA fast track designation for its immunotherapy bavituximab as a potential treatment of second-line non-small cell lung cancer (Peregrine press release).

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.