FDA approves Opdivo + Yervoy combined with limited chemotherapy as first-line treatment of metastatic or recurrent non-small cell lung cancer.- BMS

Bristol Myers Squibb announced that Opdivo (nivolumab) 360 mg plus Yervoy (ipilimumab) 1 mg/kg (injections for intravenous use) given with two cycles of platinum-doublet chemotherapy was approved by the FDA for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC) with no EGFR or ALK genomic tumor aberrations. The therapy is approved for patients with squamous or non-squamous disease and regardless of PD-L1 expression.

This application was reviewed under the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible. On May 15, the FDA approved Opdivo + Yervoy as a first-line treatment for certain patients with metastatic NSCLC whose tumors express PD-L1?1% as determined by an FDA-approved test.