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
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Ref: Exelixis | Image: Takeda
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