Bristol-Myers Squibb Company BMY announced that the FDA has cleared its intravenous human programmed death receptor-1 (PD-1) blocking antibody, Opdivo, for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR mutation or ALK translocation should have disease progression on appropriate targeted therapy before receiving Opdivo.

This approval expands Opdivo’s label which includes previously treated metastatic squamous NSCLC. The product is also approved 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. Opdivo generated revenues of $122 million in the second quarter of 2015 as compared to $40 million in the first quarter of 2015. Meanwhile, the company continues to work on further label expansion of the drug.

Opdivo is the first and only anti-PD-1 therapy approved for previously treated metastatic NSCLC (both squamous and now non-squamous) patients regardless of PD-L1 expression. Merck’s MRK PD-1 therapy, Keytruda, has been approved by the FDA for the treatment of metastatic NSCLC patients whose tumors express PD-L1 as determined by an FDA-approved test and who have disease progression on or after platinum-containing chemotherapy. We note that the biomarker testing is not required for Opdivo.

Bristol-Myers currently carries a Zacks Rank #3 (Hold). Some-better ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Eli Lilly and Company LLY. Anika holds a Zacks Rank #1 (Strong Buy), while Eli Lilly is a Zacks Rank #2 (Buy) stock.

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