Takeda and Ono’s Opdivo (nivolumab) + Cabometyx (cabozantinib) Receive MHLW’s Approval for the Treatment of Unresectable or Metastatic Renal Cell Carcinoma

Shots:

• The approval is based on P-III CheckMate -9ER study evaluating ONO’s Opdivo (240 mg, IV, q2w) + Takeda’s Cabometyx (40mg, PO, qd) vs sunitinib (50mg, PO, qd, for 4wks.) in a ratio (1:1) in patients with previously untreated advanced/mRCC
• Opdivo + Cabometyx demonstrated an improvement in 1EPs of PFS & 2EPs of OS & ORR, safety profiles were consistent with a previously reported safety profile of each product
• In the 2017 agreement with Takeda, Exelixis got exclusive rights to develop & commercialize cabozantinib in the US. In the 2011 agreement, BMS got territorial rights from Ono to develop & commercialize Opdivo globally (Ex-Japan, South Korea & Taiwan)

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