FDA Grants Licensing Application To Opdivo For The Treatment Advanced Squamous NSCLC

FDA Grants Licensing Application To Opdivo For The Treatment Advanced Squamous NSCLC

shutterstock_133427177Bristol-Myers Squibb recently announced that the FDA-provided Biologics Licensing Application (BLA) to Opdivo (nivolumab) to serve as treatment for advanced squamous non-small cell lung cancer (NSCLC) after earlier therapy.

The company explores a variety of immunotherapeutic agents for patients with different types of cancer and has also received Priority Review for their proposal. The date for Prescription Drug User Fee Act (PDUFA) is set for the 22nd of June 2015.

Lung cancer is one of the leading causes of death in the United Sates and worldwide, with non-small cell lung cancer accounting for nearly 85% of all cases. Within these, squamous NSCLC accounts for nearly 25% to 30% of all NSCLC cases.

Bristol-Myers Squibb is studying Opdivo in various tumor types, totaling more than 50 trials in over 7,000 patients worldwide. The trials have been testing Opdivo alone or in combination with other therapies.

The FDA approval was based on the promising clinical results of a Phase II open label single arm trial called CheckMate -063, which is evaluating the efficacy of Opdivo in patients with advanced squamous NSCLC that have disease progression after platinum-based therapy and at least one additional systemic treatment.

“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 Development, Bristol-Myers Squibb in a recent news 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 Opdivoavailable to the lung cancer community.”

A 2011 collaboration between Ono Pharmaceutical and Bristol-Myers Squibb provided BMS the opportunity to develop and commercialize Opdivo worldwide with the exception of Japan, South Korea and Taiwan, where Opdivo’s full rights are still retained by One Pharmaceutical. However, on the 23rd of July 2014 the collaboration between the two companies was expanded and they are now jointly developing and commercializing various immunotherapies — as monotherapies and in combination with other regiments — for patients suffering with cancer in Japan, South Korea and Taiwan.

In the United States, Opdivo is recommended as a treatment for patients that have unresectable or metastatic melanoma and disease progression after Yervoy (ipilimumab), and if BRAF V600 mutation positive, a BRAF inhibitor.

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