Merck's Keytruda Gets EU Nod as Adjuvant Therapy for Melanoma

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Merck & Co., Inc.MRK announced that the European Commission has approved its anti-PD-1 therapy, Keytruda, for the treatment of high-risk stage III melanoma patients in the adjuvant setting.

The nod was based on favorable data from the pivotal phase III KEYNOTE-054 study. The study was conducted in collaboration with the European Organization for Research and Treatment of Cancer (EORTC).

Data from the study showed that as an adjuvant treatment, Keytruda significantly prolonged recurrence free survival (RFS) post-surgery compared with placebo in patients. The drug reduced the risk of disease relapse or death by 44% compared with placebo in the overall patient population.

Keytruda is already approved in the EU as a monotherapy for treating adult patients with advanced melanoma. The approval in the adjuvant setting will help Merck gain access to a broader patient population and boost sales for this blockbuster drug.

Shares of Merck have surged 33.7% so far this year, outperforming the industry's increase of 5%.

Merck's Keytruda is already approved for use in several cancer types across different settings. Within a very short span, Keytruda has become Merck's largest product. In the first nine months of 2018, Keytruda generated sales of $5.02 billion, an almost 100% increase year over year. The drug is continuously growing and expanding into new indications.

Notably, this November, the FDA granted an approval to Merck's supplemental biologics license application (sBLA), looking to expand Keytruda's label for the treatment of advanced hepatocellular carcinoma (HCC), the most common type of liver cancer in patients, who were previously treated with Bayer/Amgen's AMGN Nexavar (sorafenib). Also, in October 2018, the FDA approved the label expansion of Keytruda as a first-line treatment for metastatic squamous non-small cell lung cancer (NSCLC), a difficult-to-treat lung cancer.

Meanwhile, the Keytruda development program is also progressing well as the drug is being evaluated for more than 30 types of cancer in above 850 analyses including several combination studies. Several regulatory decisions for new indications in the United States and in Europe are pending in 2019, which on approval, can further boost sales.

Zacks Rank & Other Key Picks

Merck currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large cap pharma sector include Bristol-Myers Squibb Company BMY and Roche Holding AG RHHBY . While Bristol-Myers sports a Zacks Rank #1 (Strong Buy), Roche carries a Zacks Rank of 2. You can see the complete list of today's Zacks #1 Rank stocks here.

Bristol-Myers' earnings estimates have been revised 6.3% upward for 2018 and 5.1% for 2019 over the past 60 days.

Roche's earnings estimates have moved 0.9% north for 2018 and 2.6% for 2019 over the past 60 days. The stock has rallied 17% in the past six months.

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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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