FDA approves BMS' Opdivo

Nivolumab (Opdivo, Bristol-Myers Squibb) has received its fifth approval across three tumor types, this time, to treat renal cancer. The drug is now approved by the FDA in America to treat patients with advanced renal cell carcinoma, who have received a certain type of prior therapy. It joins temsirolimus (Torisel, Pfizer), approved in 2007, as the only other drug that has demonstrated overall survival in renal cell cancer.
On average, patients treated with Opdivo lived more than two years longer than those who received everolimus (Afinitor, Novartis). Nivolumab was granted breakthrough therapy designation, fast-track designation and priority review status because of its potential to aid patients.
“It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease,” noted Richard Pazdur, MD, the director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement. 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, he added.
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