Bristol-Myers' Opdivo gets expanded FDA approval

The US Food and Drug Administration yesterday approved US pharma major Bristol-Myers Squibb’s (NYSE: BMY) Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy.

The drug is already approved to treat advanced melanoma and a common form of lung cancer. Opdivo is the first and only PD-1 inhibitor to deliver significant overall survival (OS) in patients with advanced RCC who have received prior anti-angiogenic therapy, the company pointed out. Opdivo generated revenues of $305 million in the third quarter of 2015 compared to $122 million in the previous quarter.

“Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.”