Exelixis and Takeda win Japanese approval for CABOMETYX in renal cell carcinoma

• Exelixis (NASDAQ:EXEL) and Takeda (NYSE:TAK) announced that the two companies along with their partner Ono Pharmaceutical received the regulatory approval for CABOMETYX (cabozantinib) in combination with OPDIVO (nivolumab) as a treatment of unresectable or metastatic renal cell carcinoma (RCC).
• Previously, the oral therapy had regulatory nod in Japan for patients with RCC and unresectable hepatocellular carcinoma (HCC), who had already received systemic therapy.
• The first commercial sale of CABOMETYX/ OPDIVO will enable Exelixis (EXEL) to receive a milestone payment of $20M from Takeda (TAK). The company is also entitled to receive further payments including sales revenue milestones and royalties on cabozantinib net sales.
• “With approximately 25,000 new cases of kidney cancer diagnosed in Japan annually, we’re pleased that this important new treatment option will now be available to Japanese patients in need of new therapies,” Exelixis (EXEL) CEO Michael M. Morrissey noted.

• In January, the U.S. FDA approved CABOMETYX / OPDIVO combination for patients with advanced renal cell carcinoma in a first line setting.