NOVELOS' LUNG CANCER DRUG RECEIVES FAST-TRACK DESIGNATION

Novelos Therapeutics announced that the FDA has granted fast-track designation to NOV-002 for use in combination with first-line chemotherapy for the treatment of advanced non-small-cell lung cancer. The fast-track designation is designed to facilitate the development and accelerate the review process for new drugs that have the potential to address a serious and unmet medical need for conditions.

Novelos now qualifies for rolling review of its NOV-002 new drug application. Rolling review saves time by allowing the FDA to review of application subsections as they become available, rather than delaying review until all components are submitted together. In addition, fast-track status results in more frequent meetings and communication with FDA reviewers. Furthermore, the NOV-002 application will be more likely to receive a priority review time of six months, rather than the standard 12 months.