FDA fast-track for Nuvelo's rNAPc2

California, USA-based drug discovery firm Nuvelo has been granted two separate fast-track designations by the Food and Drug Administration for its product candidate, rNAPc2. The first fast track designation is for first-line treatment of metastatic colorectal cancer (mCRC) to improve progression-free survival and overall survival when added to Avastin (bevacizumab)-containing 5-flurourocil -based chemotherapy regimens.

The other is for second-line treatment of mCRC to improve progression-free and overall survival when added to 5-FU-based chemotherapy regimens. Fast-track designation, which was mandated by the FDA Modernization Act of 1997, can potentially facilitate development and expedited review of Biologics License Applications, noted Nuvelo.

rNAPc2 is currently being studied in a Phase II clinical trial in subjects with mCRC, which accounted for around 55,000 colorectal cancer deaths in 2006. The primary objectives of this study are to determine the safety and efficacy of twice-weekly, subcutaneous rNAPc2 for the second-line treatment of mCRC in combination with select 5-FU-based chemotherapy regimens.