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Merck's Keytruda Gets FDA's Priority Review for Liver Cancer

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has granted priority review to a supplemental new drug application (sBLA) for its PD-L1 inhibitor, Keytruda.

With the latest filing, Merck is looking to get Keytruda approved for the treatment of advanced hepatocellular carcinoma (HCC), a form of liver cancer in patients, previously treated with systemic therapy (sorafenib).

The FDA is expected to give its verdict on Nov 9, 2018.

The sBLA was based on positive data from the phase II study KEYNOTE-224. The outcomes demonstrated that treatment with Keytruda monotherapy led to an overall response rate (ORR) of 16.3% in patients with advanced HCC. The data also showed a 1% complete response rate and a 15.4% partial response rate as a result of treatment with Keytruda.

This data was recently produced at the 2018 American Society of Clinical Oncology (ASCO) Cancers Symposium in San Francisco.

Notably, Keytruda is already marketed for several cancer indications including lung cancer, melanoma, head and neck cancer, classical hodgkin lymphoma and bladder cancer. The drug is the first anti-PD-1 therapy to gain an FDA approval and is now already approved for use in 10 different settings involving seven different tumor types. In 2018, it has already secured an FDA nod for two new indications. These include third-line treatment of adult as well as pediatric patients with primary mediastinal B-cell lymphoma (PMBCL), a type of non-Hodgkin lymphoma and second-line treatment of recurrent or metastatic cervical cancer.

The drug is also being studied for more than 30 types of cancer in more than 700 trials including in excess of 400 combination studies. Merck is collaborating with several companies like Amgen (AMGN - Free Report) , Incyte, GlaxoSmithKline (GSK - Free Report) and Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.

Keytruda is a key top-line driver for Merck and logged sales of $1.5 billion in first-quarter 2018, up 12.9% sequentially and 151% year over year. Sales continue to be driven by the launch of new indications globally.

The company is carrying out the Keytruda development program, which is progressing well with several regulatory decisions for new indications in the United States as well as in Europe expected in 2018. These label expansions, if approved, will widen the patient population base and further drive the sales higher.

Shares of Merck have increased 10% year to date versus the industry’s decline of 1.4%.


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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