Regulatory briefs on Bayer's Stivarga, Boehringer/Lilly's empagliflozin and Pfizer's Xeljanz

Drug regulator Health Canada has approved German drug major Bayer’s Stivarga (regorafenib tablets), indicated for the treatment of patients with metastatic colorectal cancer (mCRC) who have been previously treated with fluoropyrimidine-based chemotherapy, oxaliplatin, irinotecan, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

The Canadian approval of Stivarga is based on results from a pivotal Phase III study (CORRECT) 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 treatment with approved standard therapies. Stivarga (regorafenib) is an oral multi-kinase inhibitor affecting mechanisms for tumour growth and progression - angiogenesis, oncogenesis and the tumor microenvironment.

Stivarga is already approved in the USA (The Pharma Letter September 28, 2012), where the drug is co-marketed with Onyx Pharmaceuticals (Nasdaq: ONXX). According to previous statements by Bayer, Stivarga has the potential for peak annual sales of 1 billion euros ($1.3 billion) with multiple approved uses.