The FDA has put Novelos Therapeutics' experimental drug NOV-002 on the fast track. Researchers are studying it in combination with chemotherapy for the treatment of advanced non-small cell lung cancer. The move makes it more likely that the drug can get a priority review, which would shave six months off the approval process.
"Obtaining fast track for NOV-002 is a further validation of Novelos' development progress, as we commence a pivotal Phase III NSCLC trial under a SPA," said Harry Palmin, president and CEO of Novelos. "It recognizes that Novelos' clinical and non-clinical data demonstrated NOV-002's potential to address significant unmet medical need in advanced lung cancer patients."
- here's the release on the FDA action