Takeda Report Submission of NDA to MHLW for Cabometyx (cabozantinib) to Treat Advanced Hepatocellular Carcinoma in Japan

Shots:

• The NDA is based on two clinical studies, P-III CELESTIAL (XL184-309) & P-II Cabozantinib-2003 study assessing Cabometyx in patients with advanced HCC prior treated with systemic therapy
• In 2017, Exelixis and Takeda collaborated for Cabometyx in Japan, under which Exelixis will receive ~$10M milestones following the NDA submission for HCC, expected to receive in Q1’20. Additionally, Exelixis will receive ~$76M as development, regulatory and first-sale milestones for regulatory filing in previously untreated & treated RCC & HCC respectively
• Takeda provides funds for the development of therapy in Japan and is responsible for 20% of the global development cost of the therapy. Cabometyx is an approved therapy for patients with HCC prior treated with sorafenib

Click here ­to­ read full press release/ article | Ref: Exelixis | Image: Takeda