FDA Gives New Indication to Bristol-Myers Squibb's PD-1 Inhibitor Opdivo

Bristol-Myers Squibb's cancer drug Opdivo has gained a new indication as a second line treatment for metastatic squamous non-small cell lung cancer that has progressed after platinum-based chemotherapy.

The drug previously won approval for treatment of melanoma as a breakthrough therapy. Opdivo is one of a new class of immunological cancer drugs called PD-1 inhibitors, which block a protein that keeps the immune system from recognizing and attacking cancer cells.

The only other PD-1 inhibitor on the market is Merck's Keytruda (pembrolizumab). Opdivo, however, is the only PD-1 (programmed death receptor-1) therapy to demonstrate improved overall survival in previously treated metastatic squamous NSCLC, according to BMS.

In clinical trials of 389 patients, those receiving the study drug lived 3.2 months longer than those on docetaxel chemotherapy. Fifteen percent of patients experienced complete or partial tumor shrinkage, 59 percent of which lasted at least six months.

NSCLC is one of the most common causes of cancer deaths and accounts for about 85 percent of lung cancer cases, BMS says. Late-stage patients with the disease have a five-year survival rate of only 1 percent. — Lena Freund