Fierce Pharma March 8, 2024
Angus Liu

Bristol Myers Squibb’s Opdivo has won the FDA’s go-ahead in previously untreated bladder cancer. But the drug’s market potential in this indication may be limited as its PD-1 rival, Merck & Co.’s Keytruda, has impressed in a high-profile treatment combo.

The FDA on Wednesday approved Opdivo, used in combination with the chemotherapies cisplatin and gemcitabine, for the first-line treatment of unresectable or metastatic urothelial carcinoma. The regimen’s composition means that only patients who are eligible for cisplatin can receive it.

The cisplatin requirement effectively reduces the bladder cancer patient population eligible for the new regimen by half. And it puts Opdivo behind Keytruda, which in December secured approval—in its much-acclaimed combination with Astellas and Pfizer’s antibody-drug conjugate (ADC) Padcev—in a...

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