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Merck's (MRK) Keytruda Gets EU Approval for Bladder Cancer

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Merck & Co., Inc. MRK announced that its anti-PD-1 therapy, Keytruda has received approval from the European Commission (EC) for the first and second line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Keytruda has been approved as a first-line therapy for patients who cannot receive standard of care chemotherapy containing cisplatin. Keytruda was also approved as a second-line treatment for patients who have been previously treated with platinum-containing chemotherapy

The approval was expected in July as the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) had granted a positive opinion, recommending approval of Keytruda.

In the United States, Keytruda received accelerated approval for advanced bladder cancer indication in May this year.

The approvals were based on data from the phase II KEYNOTE-052 trial and the phase III KEYNOTE-045 trial. Data from these studies have shown a clinically meaningful and improved overall survival benefit of Keytruda versus chemotherapy in this difficult-to-treat population.

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

Keytruda 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 in the first half with regulatory approvals for four new indications in the U.S. and an additional indication in Europe. Important approvals include that for advanced bladder cancer, advanced microsatellite instability-high cancers and first approval as a combination therapy with Eli Lilly & Company’s (LLY - Free Report) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo),), a commonly used chemo regimen, in lung cancer. Further Keytruda data readouts are pending in the second half.

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’s shares have risen 8% this year so far against a 12% increase for the industry.

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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