Bristol-Myers Squibb's Opdivo given European approval

The European commission has approved Opdivo (nivolumab), known as Nivolumab BMS, from Bristol-Myers Squibb (NYSE: BMY) for previously-treated advanced squamous non-small cell lung cancer.

It is the first immuno-oncology agent to be approved in Europe for lung cancer, and the first major treatment advance in more than a decade, the company said. This approval is based on the results of Checkmate-017 and -063. In Phase III trial Checkmate-017, Opdivo demonstrated superior clinical benefit across all endpoints versus docetaxel, which is the current standard of care, regardless of PD-L1 expression status. This included a 41% reduction in risk of death, significantly superior overall survival rate of 42% versus 24% for docetaxel at one-year and superior durable antitumor activity.

Emmanuel Blin, senior vice president, head of commercialization, policy and operations at Bristol-Myers Squibb, said: “With the EU approval of nivolumab, patients in Europe have for the first time in more than ten years access to an entirely new treatment modality for advanced squamous non-small cell lung cancer, which has the potential to replace the current standard of care. Bristol-Myers Squibb is passionate about changing survival expectations and the way patients live with advanced cancers, and is committed to continually deliver, with speed and urgency, new approaches to pursue this goal.”