FDA to Review Melanoma Drug for the Treatment of Lung Cancer

Expanded use would include treatment of patients with advanced squamous non-small cell lung cancer who received prior therapy.

An FDA-approved drug for melanoma may soon be an option for the treatment of lung cancer as well.

The FDA last week granted Priority Review designation for Bristol-Myers Squibb’s (BMS) Biologics Licensing Application to include the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy in the approved uses of nivolumab (Opdivo).

Nivolumab was initially approved in December 2014 for patients with unresectable or metastatic melanoma who no longer respond to other drugs.

BMS supported the application’s submission with data from a phase 2 single arm, open-label study that evaluated advanced squamous NSCLC patients whose disease had progressed after both platinum-based therapy and at least one additional systemic therapy.

“With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,” BMS senior vice president Michael Giordano, MD, said in a press release. “As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.”

The FDA expects to make a decision on the application by June 22, 2015. The agency’s approval would make Opdivo the first immuno-oncology agent approved for the treatment of advanced squamous NSCLC.