Novelos and FDA agree lung cancer trial design

During the special protocol assessment (SPA) process, the FDA evaluates the adequacy of the proposed trial’s design to support the efficacy claims that will be part of the new drug application. Under FDA procedures, after an SPA is established, NDA approval will be based on meeting the primary efficacy endpoint, assuming the trial is properly conducted.

“What is agreed to during the SPA process is binding on the FDA’s review division and Novelos. As such, it removes much of the uncertainty as to whether our pivotal phase III trial design for advanced NSCLC will be adequate and sufficient to support NOV-002 approval,” said Taylor Burtis, vice president of Regulatory, Quality and Compliance of Novelos.

This randomized, open-label, international phase III trial will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in 840 patients with Stage IIIb/IV NSCLC.

The trial, with a primary efficacy endpoint of improvement in overall survival, will be conducted across approximately 10 countries and 100 clinical sites. Novelos is planning to begin patient enrollment in the third quarter of 2006.