European Commission Approves Nivolumab BMS by Bristol-Myers Squibb for NSCLC

European Commission Approves Nivolumab BMS by Bristol-Myers Squibb for NSCLC

Bristol-Myers Squibb Company recently announced the European Commission has granted approval of Nivolumab BMS as an effective post-chemotherapy treatment for locally advanced or metastatic squamous (SQ) non-small cell lung cancer (NSCLC). Nivolumab BMS, a pioneering PD-1 immune checkpoint inhibitor able to improve overall patient survival, is the first Commission-approved treatment for SQ NSCLC to advance in over 10 years in the European Union (EU). The approval now authorizes nivolumab to be marketed in all 28 countries in the territory.

“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,” said Emmanuel Blin, senior vice president, Head of Commercialization, Policy and Operations, Bristol-Myers Squibb. “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.”

The Commission based the recent approval on the positive results of Phase III study CheckMate-017 and Phase II CheckMate-063. The -017 study demonstrated nivolumab’s clinically superior performance in all endpoints compared to docetaxel, including a reduction in risk of death by 41%, increased overall survival of 42% at 1 year, and significant anti-tumor activity. In the -063 study, the researchers noted an estimated 41% 1-year survival rate, with an average OS of 8.2 months.

“Today’s approval of nivolumab for squamous non-small cell lung cancer is truly a major advance for patients fighting this devastating disease, and the providers that treat them,” said Rolf Stahel, M.D., president of the European Society of Medical Oncology and Professor at University Hospital Zurich. “Nivolumab has shown statistically significant and clinically meaningful improvement in efficacy versus standard of care in this patient population. This approval reinforces the science behind Immuno-Oncology including our understanding of the role of PD-L1 expression.”

In an earlier report on non-small cell lung cancer, the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC), whose main function is to evaluate both safety and effectiveness of human drugs (already in the market or under investigation) for cancer treatment met with Eli Lilly & Company’s managers and leading scientists to discuss their potential support to introduce necitumumab in combination with chemotherapy drugs, gemcitabine and cisplatin, as a first line-treatment for advanced squamous non-small cell lung cancer (NSCLC). Although the ODAC did not vote on immediate necitumumab approval, the vote could come by the end of the year, with the committee recognizing the potential added benefits of necitumumab as a first-line treatment for advanced squamous NSCLC.


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