US FDA fast-tracks Novelos' NOV-002

USA-based Novelos Therapeutics says that the Food and Drug Administration 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 firm noted that the program is designed to accelerate the development and review process for new drugs that have the potential to address a serious and unmet medical need.

In a controlled randomized USA-based Phase I/II clinical trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response and higher tolerance of chemotherapy versus the control group. In a controlled randomized Russian trial, in combination with cisplatin-based chemotherapy, NOV-002 increased one-year survival from 17% to 63%. The firm recently finalized a Special Protocol Assessment with the FDA for a single pivotal Phase III trial in advanced NSCLC for the agent in combination with first-line chemotherapy, and patient enrollment is expected to begin this quarter.

Novelos noted that NOV-002 now qualifies for a rolling New Drug Application review, a process that it hopes will save time by allowing subsections of the application to undergo review as they become available, rather than delaying it until all NDA components are submitted together. Furthermore, the NOV-002 application will be more likely to receive a priority review of six months, rather than the standard 12 months, the firm noted.