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Merck's Ketruda Gets Positive CHMP Opinion for Lymphoma

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Merck & Co., Inc. (MRK - Free Report) recently announced that its anti-PD-1 therapy, Keytruda, has received positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) for the treatment of patients with relapsed or refractory classical hodgkin lymphoma (cHL).

Merck is looking to get Keytruda approved for the treatment of adult patients with relapsed or refractory cHL, who have failed autologous stem cell transplant (ASCT) and brentuximab vedotin (BV) of for those who are transplant-ineligible and have failed BV. A decision on approval is expected in the second quarter of 2017.

Earlier this month, Keytruda received approval in the U.S. for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who had relapsed after three or more prior lines of therapy. This was the first time that Merck gained approval for hematologic malignancy.

Keytruda is already approved in the U.S. for the treatment of previously untreated metastatic non-small cell lung cancer (NSCLC) in patients whose tumors have high levels of PD-L1. Also, the therapy is applicable for previously treated metastatic NSCLC in patients whose tumors have PD-L1 as well as advanced melanoma. Keytruda is also apt for previously treated recurrent or metastatic head and neck cancer (HNSCC).

The positive opinion was based on data from two multicenter, open label studies – KEYNOTE-087 and KEYNOTE-013.

Merck’s shares gained 7.3% so far this year, outperforming an increase of 6.1% witnessed by the Zacks classified Large-Cap Pharma industry.



Per the company’s press release, approximately 66,000 patients suffered from Hodgkin lymphoma in 2012, leading to 25,500 deaths. cHL accounts for about 95% of all cases of Hodgkin lymphoma in developed countries. Hence, the drug has huge scoped of growth across the globe.

We remind the investors that new products like Keytruda have been contributing meaningfully to Merck’s top line growth. In 2016, Keytruda garnered sales of $1.4 billion, up 148% year over year. Sales were driven by label as well as geographical expansion.

Keytruda is the first anti-PD-1 therapy to gain FDA approval and is being studied for more than 30 types of cancer in 400 trials, half of which are combination with other cancer drugs. has collaborated with several companies like Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) for the evaluation of Keytruda in combination with other regimens. The last few months saw a series of positive developments on Keytruda, raising sales expectations for the drug. Further label expansion of the drug should significantly boost Merck’s top line.

Zacks Rank

Merckcurrently 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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