EMA Committee Recommends BMS’ Nivolumab for Non-Small Cell Lung Cancer
Bristol-Myers Squibb reports that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung cancer (NSCLC) after prior chemotherapy in adults. The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
Nivolumab was approved in Japan in July 2014 for the treatment of patients with unresectable melanoma. In the US, the Food and Drug Administration (FDA) granted approved nivolumab 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. On March 4, 2015, nivolumab received its second FDA approval for the treatment of patients with metastatic squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Bristol-Myers Squibb has a broad, global development program to study nivolumab in multiple tumor types consisting of more than 50 trials, as a monotherapy or in combination with other therapies, in which more than 8,000 patients have been enrolled worldwide.
Source: Bristol-Myers Squibb