- Bayer announced Wednesday its cancer drug Stivarga (regoranfenib) extended overall survival time for patients with unresectable hepatocellular carcinoma (HCC). The drug met its primary endpoint in a phase 3 trial.
- Stivarga is currently indicated for secondary treatment of patients with metastatic colorectal cancer (CRC) and treatment of advanced gastrointestinal stromal tumors (GIST)
- Liver cancer is the sixth most common cancer in the world, and the second lead of cancer-related death globally.
Liver cancer in general, and hepatocellular carcinoma (HCC) in particular, represents a global unmet medical need. Bayer enrolled 573 patients in the randomized, placebo-controlled phase 3 trial.
A third indication for Stivarga would help maintain its momentum and steady sales growth over the past year. According to estimates from Drug Analyst Equity Research, Stivarga is on pace to become Bayer's 12th top-selling drug this year, with anticipated sales of €333 million. The drug earned €313 million in sales last year.
If Stivarga is approved for the HCC indication, the revenue potential in that space is significant because of the increasing prevalence of HCC. Bayer plans to submit data from this trial in support of a marketing authorization for treatment of HCC sometime this year.