US FDA Accepts Bristol-Myers Squibb’s sBLA for Opdivo (nivolumab) to Include Previously Treated Squamous NSCLC

US FDA Accepts Bristol-Myers Squibb’s sBLA for Opdivo (nivolumab) to Include Previously Treated Squamous NSCLC

The US Food and Drug Administration recently accepted Bristol-Myers Squibb Company’s supplemental Biologics License Application (sBLA) for Opdivo (nivolumab) for review as a treatment for previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC). This supplemental application is requesting an expansion of the drug’s current treatment indication to include patients with previously treated squamous (SQ) NSCLC. The company expects the FDA’s decision by January 2, 2016.

The application follows the FDA’s acceptance of Opdivo for priority review and qualification for Breakthrough Therapy Designation, which highlights the drug’s potential in treating a disease with significantly unment medical needs and its success at producing favorable results from clinical trials.

“We are pleased with this important step forward in the FDA’s consideration to expand the use of Opdivo to include non-squamous non-small cell lung cancer patients, as well as the Breakthrough Therapy Designation,” said Michael Giordano, senior vice president, head of Development, Oncology, Bristol-Myers Squibb. “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.”

The sBLA is backed by results from CheckMate -057, a Phase 3 study designed to evaluate the survival of patients with NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. The favorable findings of a separate study, Checkmate -017, formed the basis of the current lung cancer indication; study -017 evaluated the survival of patients with SQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen. In both studies Opdivo was able to demonstrate an overall survival benefit.

In other recent lung cancer-related news, Boehringer Ingelheim recently announced that its product Giotrif/Gilotrif (generically known as afatinib) has been accepted for final review by the US Food and Drug Administration and the European Medicines Agency for the treatment of patients with squamous cell carcinoma of the lung after failing on routine chemotherapy measures.

This review comes on the heels of the LUX-Lung 8 Phase III clinical trial on afatinib compared to erlotinib, another chemotherapy agent used to treat squamous cell carcinoma of the lung. The study revealed that afatinib prolonged survival rate and improved quality of life in patients who took the once-daily drug when compared to those who instead took erlotinib.

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