Japan nod for HCC indication on Takeda's Cabometyx

Shares of US drugmaker Exelixis (Nasdaq: EXEL) gained 3.6% to $19.41 on Friday, after it revealed that its Japanese marketing partner, Takeda Pharmaceutical (TYO: 4502), had received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) to manufacture and market Cabometyx (cabozantinib) as a treatment for patients with unresectable hepatocellular carcinoma (HCC) that has progressed after prior systemic therapy.

Takeda’s application is based on the results of two clinical trials in patients with advanced HCC who had received prior systemic therapy: CELESTIAL (XL184-309), a global, randomized, placebo-controlled, double-blind Phase III clinical trial, and Cabozantinib-2003, a Phase II clinical trial conducted in Japan. The CELESTIAL trial was the basis for the Cabometyx approvals in the USA and the European Union for the treatment of patients with HCC who have been previously treated with sorafenib.

“Hepatocellular carcinoma causes approximately 30,000 deaths in Japan each year and is a leading cause of cancer-related death worldwide,” said Michael Morrissey, president and chief executive of Exelixis. “The approval of Cabometyx in Japan is an exciting next step toward bringing this treatment to liver cancer patients who otherwise have limited treatment options following prior systemic therapy. We’re proud to collaborate with Takeda as we work to bring this treatment to patients in Japan,” he added.