FDA Grants Priority Review to Bristol-Myers Squibb’s PD-1 Inhibitor for Treatment of Lung Cancer

Bristol-Myers Squibb

US health regulators have accepted, and granted Priority Review, for Bristol-Myers Squibb Company’s (BMS) lung cancer drug.

BMS announced that the US Food and Drug Administration (FDA) has accepted for filing and review the Biologics License Application (BLA) for Opdivo (nivolumab) for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The agency also granted Priority review of the application, with an expected decision date of June 22, 2015.

The agency accepted and granted the drug priority review based on data from the mid-stage trial, CheckMate -063. The Phase II single arm study was designed to evaluate advanced squamous NSCLC patients who had progressed after both platinum-based therapy and at least one additional systemic therapy. In the trial, treatment with Opdivo demonstrated an overall response rate (ORR) of 15 percent. Additionally, 41 percent of patients in the trial survived at least one year, compared with an average survival rate of 5.5 percent to 18 percent.

“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,” said Michael Giordano, MD, senior vice president, Head of Oncology, Bristol-Myers Squibb. “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.”

In the US, lung cancer is one of the leading causes of cancer-related deaths. NSCLC, one of the most common types of lung cancer, accounts for approximately 85 percent of cases. NSCLC includes three main subtypes including squamous NSCLC, which accounts for approximately 25 to 30 percent of all lung cancers.

Opdivo works by inhibiting the PD-1 protein on cells, which blocks the body’s immune system from attacking tumors. Merck is also studying its PD-1 inhibitor, Keytruda, in lung cancer. In January, Merck revealed that the drug was ahead of schedule and the company expected to complete an FDA application by mid-2015.

BMS gained rights to Opdivo through its collaboration agreement with Ono Pharmaceutical. In 2011, BMS expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono retains all rights to the compound. The drug has already received FDA approval for the treatment of patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor.

Source: Bristol-Myers Squibb Company

Last updated: 3/2/15; 2:00pm EST

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