US FDA grants Peregrine Fast Track designation for bavituximab in NSCLC
US drugmaker Peregrine Pharmaceuticals (Nasdaq: PPHM) has received Fast Track designation from the US Food and Drug Administration for its investigational immunotherapy bavituximab for the treatment of second-line non-small cell lung cancer (NSCLC).
The news pushed Peregrine’s shares up 25% to $1.81 by mid-morning trading. The designation follows the start of the SUNRISE Phase III clinical trial comparing bavituximab plus the chemotherapy docetaxel against placebo plus docetaxel in this indication.
Robert Garnick, head of regulatory affairs at Peregrine, said: "The fast track designation is a milestone for the SUNRISE trial program and represents a step closer to bringing bavituximab to the market. We are very pleased that the FDA has recognized 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."
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