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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