Novelos Therapeutics has received FDA approval for Phase III trials of the company's NOV-002 in advanced non-small cell lung cancer (NSCLC) in combination with first-line chemotherapy.
The FDA agreed that a single well-controlled study would be sufficient to support licensure of NOV-002 for the first-line treatment of chemotherapy-naive Stage IIIb/IV NSCLC patients. Novelos will seek to finalize the study design under a special protocol assessment during the first half of 2006. The primary endpoint of the pivotal study will be overall survival. Enrollment is expected to begin in the third quarter of 2006.