FDA approves regorafenib tablets for treatment of metastatic colorectal cancer

FDA has approved regorafenib (Stivarga, Bayer HealthCare) tablets for the treatment of patients with metastatic colorectal cancer (mCRC) 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).

Regorafenib 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.

Regorafenib’s approval is based on results from the pivotal phase 3 (CORRECT [or Colorectal cancer treated with regorafenib or placebo after failure of standard therapy]) study that demonstrated a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) compared to placebo in patients with mCRC whose disease had progressed after approved standard therapies.

“The U.S. approval of Stivarga is an important milestone for Bayer as it marks the first approval of this innovative cancer treatment to fulfill a significant unmet medical need in the treatment of metastatic colorectal cancer,” Jörg Reinhardt, CEO, Bayer HealthCare, said in a company press release.

In the CORRECT trial, regorafenib plus best supportive care (BSC) significantly improved OS (HR=0.77, 2-sided P-value=.0102) and PFS (HR=0.49, 2-sided P-value

The most frequently observed adverse drug reactions (≥30%) in patients receiving regorafenib were asthenia/fatigue, decreased appetite and food intake, hand-foot-skin reaction/palmar-plantar erythrodysesthesia, diarrhea, mucositis, weight loss, infection, hypertension, and dysphonia. The most serious adverse drug reactions in patients receiving regorafenib were hepatotoxicity, hemorrhage, and gastrointestinal perforation. Primary efficacy and safety data for this trial were first reported at the Annual Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO-GI) in January 2012 and additional data were presented at the ASCO Annual Meeting in June 2012.

Stivarga was developed and reviewed under the fast track program and received priority review designation from FDA.

CRC is the fourth most common cancer worldwide, with more than 1 million cases occurring every year. The mortality rate from CRC is approximately half of its global incidence. The 5-year survival estimate for CRC on average is 55%, but is highly variable dependent on the stage of the disease (from 74% for patients with stage I disease to only 6% for stage IV patients).

 In mCRC, KRAS status is an important biomarker and can be a predictor of treatment response. Approximately 40% of colorectal cancers are characterized by mutations in the KRAS gene. Some of the CRC therapies currently available have demonstrated efficacy only in patients without KRAS mutations. 


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