Astrazeneca's (AZN) durvalumab, in combination with Bacillus Calmette-Guerin, received approval by the Food and Drug Administration to treat adults with BCG-naive, high-risk non-muscle invasive bladder cancer, the FDA said Thursday.

Durvalumab's efficacy was evaluated in the Potomac study, a randomized, open-label, multi-center trial of 1,018 patients with high-risk NMIBC following transurethral resection of bladder tumor, according to the statement.

A statistically significant improvement in disease-free survival was observed with durvalumab plus BCG induction and maintenance compared with BCG induction and maintenance alone.

The recommended durvalumab dose for patients weighing at least 30 kilograms is 1,500 mg every four weeks for 13 cycles, in combination with BCG induction and maintenance treatment. Treatment should continue until disease recurrence, progression, unacceptable toxicity, or a maximum of 13 cycles.

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