FDA Accepts sNDA for BMS’ Cancer DrugBy
The US Food and Drug Administration (FDA) has accepted for filing and review Bristol-Myers Squibb’s supplemental biologics license application (sBLA) for Opdivo (nivolumab) for treating previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC). This sBLA seeks to expand the current indication for Opdivo in patients with previously treated squamous (SQ) NSCLC. The projected FDA action date is January 2, 2016.
The agency has also granted this application priority review, and Opdivo breakthrough therapy designation for this indication. Breakthrough therapy designation requires preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that has received approval from the FDA as a monotherapy in two cancer indications: unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor, and for metastatic squamous non-small cell lung cancer with progression on or after platinum-based chemotherapy. On July 20, the European Commission approved Nivolumab BMS for the treatment of locally advanced or metastatic SQ NSCLC after prior chemotherapy.
Source: Bristol-Myers Squibb