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Merck's (MRK) Keytruda Gains FDA Nod for Label Expansion

MerckMRK announced that its anti-programmed death receptor-1 (PD-1) therapy, Keytruda, has been approved by the FDA for the treatment of metastatic non-small cell lung cancer (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.

The FDA granted accelerated approval to Keytruda based on an encouraging tumor response rate and durability of response. Continued approval for the melanoma indication depends on data from the confirmatory studies.

Keytruda was the first anti-PD-1 therapy to gain approval in the U.S. last year for the treatment of patients suffering from unresectable or metastatic melanoma whose disease progressed after treatment with Bristol-Myers Squibb Company's BMY Yervoy (ipilimumab) and a BRAF inhibitor, if the BRAF V600 mutation is positive.

Keytruda generated sales of $110 million in the second quarter of 2015, up from $83 million in the first quarter of 2015. Meanwhile, Merck continues to work on expanding Keytruda's label further. Label expansion into additional indications will give Keytruda access to an expanded patient population and increase the commercial potential of the drug.

Keytruda is the first and only anti-PD-1 therapy approved for both squamous and non-squamous metastatic NSCLC. Bristol-Myers' PD-1 blocking antibody, Opdivo, is indicated for the treatment of patients with metastatic squamous NSCLC with progression on or after platinum-based chemotherapy

Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Anika Therapeutics Inc. ANIK and Regeneron Pharmaceuticals, Inc. REGN . Both Regeneron and Anika hold a Zacks Rank #1 (Strong Buy).

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REGENERON PHARM (REGN): Free Stock Analysis Report

BRISTOL-MYERS (BMY): Free Stock Analysis Report

MERCK & CO INC (MRK): Free Stock Analysis Report

ANIKA THERAPEUT (ANIK): Free Stock Analysis Report

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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.


The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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