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Takeda Files NDA for Cabometyx (cabozantinib) to MHLW for Advanced Renal Cell Carcinoma in Japan

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Takeda Files NDA for Cabometyx (cabozantinib) to MHLW for Advanced Renal Cell Carcinoma in Japan

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  • The submission is based on METEOR- CABOSUN and Takeda’s bridging study. METEOR & CABOSUN studies result assessing Cabometyx vs everolimus & sunitinib in patients with RCC + prior treated with at least one VEGFR-TKI inhibitor & untreated advanced RCC with intermediate/poor-risk disease respectively
  • In Q2’19- Exelixis is expected to receive $10M as milestones from Takeda under a license agreement signed by the companies in H1’17. Additionally- Takeda has an option to co-fund ongoing P-III CheckMate 9ER study assessing cabozantinib + nivolumab vs sunitinib for untreated advanced RCC
  • Cabometyx (cabozantinib) is a VEGFR-TKI inhibitor and is approved for the treatment of patients with advanced RCC & HCC previously treated with sorafenib. In 2016- Ipsen acquired exclusive rights to develop & commercialize Cabometyx (Ex the US & Japan) from Exelixis

Ref: Exelixis | Image:Takeda

Click here to­ read the full press release 

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