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Merck's Keytruda Gets FDA Nod for High-Risk Bladder Cancer

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted approval to its blockbuster PD-L1 inhibitor, Keytruda for a bladder cancer indication. The latest approval allows use of Keytruda as a monotherapy to treat patients with high-risk non-muscle invasive bladder cancer (NMIBC), unresponsive to Bacillus Calmette-Guerin (BCG) — a therapy widely used in the management of bladder cancer. These patients have carcinoma in situ (CIS) with or without papillary tumors and are ineligible for or have elected not to undergo cystectomy.

The approval was expected as in December the FDA’s Oncologic Drugs Advisory Committee (ODAC) had voted 9-4 in favor of approving Keytruda for the indication. The FDA approval was based on data from the phase II KEYNOTE-057 study.

In bladder cancer, Keytruda is already approved for first- as well as second-line treatment of certain patients with locally advanced or metastatic urothelial carcinoma, a type of bladder cancer.

Merck’s shares have risen 17.5% this year so far compared with the industry’s increase of 11.4%.



Keytruda, Merck’s biggest product, is already approved for use in 20 indications across 12 different tumor types in the United States.

Keytruda generated sales of almost $8 billion in the first nine months of 2019, up around 63% year over year. The drug’s sales were driven by the launch of new indications globally. Keytruda sales are benefiting from strong momentum in the indication of first-line lung cancer.

The Keytruda development program is also progressing well with Merck spending billions on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1000 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen (AMGN - Free Report) , Incyte, Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens. 

Undoubtedly, Keytruda’s solid growth prospects are based on increased utilization,approval for new indications and expectation of additional approvals worldwide.

Merck currently 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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