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Merck's Keytruda Gets FDA's Priority Tag in Bladder Cancer

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Merck & Co., Inc. MRK announced that the FDA has granted priority review status to yet another supplemental new drug application (sNDA) for its blockbuster PD-L1 inhibitor, Keytruda. The sNDA is seeking approval of Keytruda, as a monotherapy, to treat patients with high-risk non-muscle invasive bladder cancer (NMIBC), unresponsive to Bacillus Calmette-Guerin (BCG) therapy - a therapy widely used in the management of bladder cancer.

The sNDA was based on data from the phase II KEYNOTE-057 study wherein Keytruda led to a complete response rate of nearly 40%. Meanwhile, FDA’s Oncologic Drugs Advisory Committee (ODAC) is due to discuss this sNDA at its Dec 17 meeting. With the FDA granting priority review, Merck expects a decision is in January 2020

Merck’s shares have risen 13.9% this year so far compared with the industry’s increase of 6.4%.



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 above 1000 studies including 600 plus combination studies. Merck is collaborating with several companies including Amgen AMGN, Incyte, Glaxo (GSK - Free Report) and Pfizer PFE 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 #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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