EC OKs BMS Nivolumab for Lung Cancer

The European Commission has approved Bristol-Myers Squibb’s Nivolumab BMS (nivolumab) for treating locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC) after prior chemotherapy. Nivolumab is a PD-1 immune checkpoint inhibitor, and one of the company’s key anti-cancer drugs. The approval for SQ NSCLC allows for the marketing of nivolumab in all 28 member states of the European Union

In June 2015, the European Commission Opdivo (nivolumab) for treating advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. Bristol-Myers Squibb submitted two separate marketing authorization Applications, one in advanced melanoma under the tradename Opdivo and one for SQ NSCLC under the Nivolumab BMS tradename in order to accelerate availability of nivolumab in both indications. The goal is to have these two marketing authorizations “reconciled” into a single marketing authorization, under the Opdivo brand name toward the end 2015.

In the US, Opdivo is approved 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. In March 2015, Opdivo received its second US Food and Drug Administration approval for the treatment of patients with metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. Opdivo was first approved in Japan in July 2014 for treating unresectable melanoma.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials, as a monotherapy or in combination with other therapies , in which more than 7,000 patients have been enrolled worldwide.

In 2011, through a collaboration agreement with Ono Pharmaceutical, Bristol-Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to the compound at the time. In July 2014, Bristol-Myers Squibb and Ono Pharmaceutical further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens in Japan, South Korea, and Taiwan.

Source: Bristol-Myers Squibb

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