FDA grants breakthrough therapy designation, priority review to Opdivo for nonsquamous NSCLC

The FDA granted breakthrough therapy designation and priority review to nivolumab for the treatment of patients with nonsquamous non–small cell lung cancer who have previously received treatment, according to a press release from the drug’s manufacturer.

The FDA based its decision in part on the results of CheckMate 057, a phase 3 trial that evaluated second-line nivolumab (Opdivo, Bristol-Myers Squibb) in patients who had progressed during or after treatment with a platinum doublet-based chemotherapy regimen. Patients who received nivolumab demonstrated an OS benefit compared with patients who received docetaxel (median OS, 12.2 months vs. 9.4 months; HR = 0.73; 95% CI, 0.59-0.89).

Nivolumab is currently indicated for patients with previously treated squamous NSCLC, based on results of the CheckMate 017 trial. The projected FDA action date for the supplemental biologics license application is Jan. 2, 2016.

“We are pleased with this important step forward in the FDA’s consideration to expand the use of Opdivo to include nonsquamous non–small cell lung cancer patients, as well as the breakthrough therapy designation,” Michael Giordano, MD, senior vice president and head of development of oncology at Bristol-Myers Squibb, said in the press release. “From its inception, our clinical development program for Opdivo in lung cancer has been based on our deep scientific expertise and always with the goal of helping patients achieve gains in survival. We look forward to working with the FDA to make this treatment option available to more patients.”