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Bristol Myers' (BMY) Opdivo Combo Gets EU Nod for First-Line RCC

Bristol-Myers Squibb Company BMY announced that the European Commission (“EC”) has approved its PD-1 inhibitor Opdivo (nivolumab) in combination with Exelixis’ EXEL Cabometyx (cabozantinib) for first-line treatment of adult patients with advanced renal cell carcinoma (“RCC”).

The EC nod was based on data from the phase III CheckMate -9ER study which evaluated Opdivo + Cabometyx in the given patient population. Data from the same showed that treatment with Opdivo + Cabometyx led to superior efficacy as compared to Pfizer’s PFE Sutent (sunitinib) across three key endpoints – progression-free survival which was the primary endpoint, and objective response rate as well as overall survival.

Also, the combo of Opdivo plus Cabometyx was generally well tolerated, with a low rate of treatment-related discontinuations.

Please note that Opdivo in combination with Cabometyx was approved for first-line treatment of patients with advanced RCC in the United States in January this year.

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Shares of Bristol Myers have increased 2.8% so far this year against the industry’s decrease of 5.1%.

price chart for BMY
price chart for BMY


We remind investors that, apart from advanced RCC, Opdivo is approved in several countries for various other cancer indications.

Opdivo generated sales worth $6.9 billion in 2020, reflecting a decrease of 3% year over year. The drug faces stiff competition from Merck’s MRK Keytruda and Roche’s Tecentriq in key indications.

Please note that Keytruda in combination with Inlyta is also approved for the first-line treatment of patients with advanced RCC. This is likely to be a tough competition for Opdivo in the given market space.

Zacks Rank

Bristol-Myers currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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