FDA approves BMS' Opdivo for kidney cancer a week after granting priority review

Dr. Richard Pazdur

In another striking FDA turnaround for Bristol-Myers Squibb's ($BMY) Opdivo, the agency has approved it for treating advanced renal cell carcinoma just a week after granting priority review.

The agency said Opdivo, which is intended for use in renal cell carcinoma (RCC) in patients who have received prior antiangiogenic therapy, becomes only the second drug approved for treating the condition and the first in nearly 9 years. Pfizer's Torisel was approved in 2007.

Commenting on Opdivo's approval, Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products at FDA, said in the agency's announcement, "It is one of few therapies that have demonstrated the ability to extend patients' survival in treating this disease."

The so-called checkpoint inhibitor is designed to galvanize an immune system attack on tumors by blocking a pathway called PD-1, which, left unchecked, allows cancer cells to pass undetected by the body's natural defenses.

The FDA had granted the drug its "breakthrough" tag in September for kidney cancer based on data from Bristol-Myers' CheckMate series of Opdivo studies, which marked the first time any checkpoint inhibitor had proven itself in a kidney cancer trial--and the first time any med had demonstrated an overall survival benefit as a primary endpoint compared with the standard of care in the second-line setting.

The drug, which is expected to quickly reach blockbuster status, has already been approved for treating melanoma and two forms of lung cancer. "Opdivo's extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors," Dr. Pazdur said. The agency's Opdivo nod to treat squamous non-small cell lung cancer that has advanced despite chemotherapy was even faster, coming within days of getting the application.

Getting a host of approvals is exactly what BMS is shooting for with Opdivo. It has been in a race with Merck's ($MRK) checkpoint inhibitor, Keytruda, to rack up indications. Though Merck's med was the first to win the FDA's favor, scoring an approval in advanced melanoma, it wasn't long before Opdivo landed that thumbs up--and followed with a lung cancer approval in short order after that.

- here's the FDA release

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