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Merck's (MRK) Keytruda Gets FDA Nod for Two New Indications

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Merck & Co., Inc. (MRK - Free Report) announced that the FDA has approved two new indications for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy.  The drug is now approved for the first line treatment of patients with locally advanced or metastatic urothelial carcinoma, who are ineligible for cisplatin-containing chemotherapy.

The first indication is approved under the accelerated approval based on tumor response rate and duration of response. The approval is based on data from a single-arm study, KEYNOTE-052, investigating Keytruda in 370 patients with locally advanced or metastatic urothelial carcinoma who were not eligible for cisplatin-containing chemotherapy.

The second approval came in for patients in second line setting for the treatment of patients with locally advanced or metastatic urothelial carcinoma, who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The second-line approval is based on data from a KEYNOTE-045 study, evaluating Keytruda in patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum-containing chemotherapy.

Notably, Keytruda is approved for use in these indications at a fixed dose of 200 mg every three weeks until disease progression or unacceptable toxicity, or up to 24 months in patients without disease progression.
Merck’s shares has rallied 8.5% year to date, comparing favorably with the Zacks classified Large-Cap Pharma industry’s gain of 8.4%.

We note that 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 express high levels of PD-L1 and previously treated metastatic NSCLC in patients whose tumors express PD-L1, as well as advanced melanoma, and previously treated recurrent or metastatic head and neck cancer (HNSCC).

In fact, Keytruda is the first anti-PD-1 therapy to gain the FDA approval and is being studied for more than 30 types of cancer in 500 trials, half in combination with other cancer drugs. Also, Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) and Pfizer Inc. (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens. The last few months too witnessed a series of positive news on Keytruda, thereby raising sales expectations for the drug. Further, label expansion of the drug is expected to significantly boost Merck’s top line, going forward.


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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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