Merck's (MRK) Keytruda Gets FDA Nod For Solid Tumor Cancers

Merck & Co., Inc. (NYSE:MRK) announced that its anti-PD-1 therapy, Keytruda, has received accelerated approval for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. Also, the label will be expanded to include MSI-H or mismatch repair deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.

In a separate press release, Merck announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) for label expansion of Keytruda for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma. The FDA is expected to give its decision on Sep 22.

Presently, Keytruda is approved in the U.S. and EU 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. In the U.S. it is also approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).

Merck’s shares are up 9.8% year to date, comparing unfavorably with an increase of 10.2% witnessed by the Zacks classified Large-Cap Pharma industry.

The last few months witnessed a series of regulatory approvals for label expansion of Keytruda that should drive sales going forward. Keytruda brought in sales of $584 million in first-quarter 2017, up 20.9% sequentially and 134.5% year over year.

Earlier this month, the company announced that FDA has approved two new bladder cancer indications for Keytruda. Also, this month, the FDA granted accelerated approval to Keytruda for use in combination with Eli Lilly & Company’s (NYSE:LLY) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo), a commonly used chemo regimen, for the first-line treatment of metastatic NSCLC, irrespective of PD-L1 expression. Note that this is the first FDA approval for Keytruda as combination therapy.

In Mar/Apr 2017, Keytruda received FDA and EU approval for refractory classical Hodgkin lymphoma (cHL) - the first Keytruda approval for hematologic malignancy indication.

Keytruda is the first anti-PD-1 therapy to gain FDA approval and is continuously growing and expanding into new indications and markets globally. Especially, its sales received a boost with the approval in the first-line lung cancer setting. With the recent label expansions, sales should pick up further in the upcoming quarters.

Meanwhile, Keytruda is being studied for more than 30 types of cancer in 500 trials. Almost 50% of these trials are in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. (NASDAQ:AMGN) , Incyte, GlaxoSmithKline plc (NYSE:GSK) ) and Pfizer (NYSE:PFE) separately for the evaluation of Keytruda in combination with other regimens

Merck 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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