Onyx and Bayer HealthCare announced that the FDA has approved Stivarga (regorafenib tablets) for the treatment of patients with metastatic colorectal cancer who have been previously treated with currently available therapies (including fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy).
This approval is based on study results from the Phase 3 CORRECT (Colorectal cancer treated with regorafenib or placebo after failure of standard therapy) that demonstrated improvement in overall survival [HR=0.77 (95% CI, 0.64–0.94), two-sided p=0.0102] and progression-free survival [HR=0.49 (95% CI, 0.42–0.58), two-sided p<0.0001] compared to placebo in patients with metastatic colorectal cancer whose disease had progressed after approved standard therapies. Median overall survival was 6.4 months with Stivarga vs. 5.0 months with placebo; median PFS was 2.0 months with Stivarga vs. 1.7 months with placebo.
Stivarga is an oral multi-kinase inhibitor that inhibits various kinases within the mechanisms involved in tumor growth and progression–angiogenesis, oncogenesis and the tumor microenvironment.
Stivarga will be available in 40mg strength film-coated tablets in 28-count bottles.
For more information call (866) 639-2827 or visit www.stivarga-us.com.