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Merck's Keytruda Gets FDA Nod for Advanced Gastric Cancer

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Merck & Co., Inc. MRK announced that the FDA has approved its anti-PD-1 therapy, Keytruda as a monotherapy for third-line treatment of advanced gastric or gastroesophageal junction adenocarcinoma.

Keytruda is already approved for many types of cancers and treatment settings including lung cancer, melanoma, head and neck cancer, classical hodgkin lymphoma and bladder cancer.

The drug’s label has now been expanded to include treatment of heavily pre-treated patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction cancer whose tumors express PD-L1, as determined by an FDA approved test. However, the approval for this tenth new indication for Keytruda comes on an accelerated basis with continued approval dependent on further benefit demonstrated from clinical studies.

The FDA approval was based on data from the KEYNOTE-059 study.

Keytruda is key top line driver for Merck and it brought in sales of $881 million in second-quarter 2017, up 51% sequentially and 180% year over year.Sales continue to be driven by launch of new indications globally. Keytruda sales in the U.S. gained particularly from strong momentum in the new indication of first-line lung cancer. Outside U.S, Keytruda sales were primarily driven by the melanoma indication.

Meanwhile, the Keytruda development program also significantly advanced this year with regulatory approvals for four new indications in the U.S. and two additional indications in Europe. Important approvals include that for advanced bladder cancer in both United States and the EU, advanced microsatellite instability-high cancers and first approval as a combination therapy with Eli Lilly & Company’s LLY cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo),), a commonly used chemo regimen, in lung cancer. Further Keytruda data readouts are pending this year.

Keytruda is continuously growing and expanding into new indications and markets globally. Keytruda is being studied for more than 30 types of cancer in more than 550 studies, including more than 300 combination studies.Merck is collaborating with several companies including Amgen, Inc. AMGN, Incyte, Glaxo and Pfizer, Inc. PFE separately for the evaluation of Keytruda in combination with other regimens.

Merck carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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Pfizer, Inc. (PFE) : Free Stock Analysis Report
 
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