FDA Grants Early Approval to Bristol-Myers Squibb’s Opdivo for Lung Cancer

The US Food and Drug Administration (FDA) expanded approval of Bristol-Myers Squibb’s (BMS) Opdivo (nivolumab) to treat patients with advanced squamous non-small cell lung cancer (NSCLC).

The approval comes just days after the agency accepted BMS’ application and granted the drug priority review. The FDA was scheduled to make a decision on whether to approve the drug by June 22, 2015, meaning that the drug was cleared by the agency more than three months ahead of schedule.

The drug is now the first cancer immunotherapy approved for this indication. The drug is designed to inhibit the PD-1 protein on cells, which blocks the body’s immune system from attacking tumors. The approval gives BMS an advantage over competitor Merck, which is expected to complete an application for its Keytruda in lung cancer by mid-2015.

“The FDA worked proactively with the company to facilitate the early submission and review of this important clinical trial when results first became available in late December 2014,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “This approval will provide patients and health care providers knowledge of the survival advantage associated with Opdivo and will help guide patient care and future lung cancer trials.”

Opdivo’s expedited lung cancer approval is based on data from the mid-stage trial, CheckMate -063. In the Phase II trial, 41 percent of patients survived at least one year, compared with an average survival rate of 5.5 percent to 18 percent. Additionally, the drug demonstrated an overall response rate (ORR) of 15 percent.

Lung cancer is the leading cause of cancer death in the US, with an estimated 224,210 new diagnoses and 159,260 deaths in 2014. NSCLC is the most common type of lung cancer, affecting seven out of eight lung cancer patients.

Source: US Food and Drug Administration

Last updated: 3/4/15; 4:00pm EST

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