Merck's (MRK) Keytruda Gets FDA Nod for Lymphoma Indication
Merck & Co., Inc. MRK announced that it has received FDA approval for its anti-PD-1 therapy, Keytruda for the treatment of patients with refractory classical Hodgkin lymphoma (cHL) or who had relapsed after three or more prior lines of therapy. This is the first time that Merck has 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 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).
Merck’s shares are up 9% so far this year, comparing favorably with an increase of 6.6% witnessed by the Zacks classified Large-Cap Pharma industry.
We note that in Apr 2016, the FDA granted Breakthrough Therapy designation to the drug for the cHLindication. The approval was based on positive data from KEYNOTE-087 trial. Keytruda has been approved to be given intravenously every three weeks at a fixed dose of 200 mg for adult patients and 2 mg/kg for paediatric patients in the indication.
We remind investors that the supplemental Biologics License Applications (sBLA) for this indication was reviewed under the FDA’s Accelerated Approval program. However, continued approval will depend upon the verification and description of clinical benefit in confirmatory studies
New products like Keytruda have been contributing meaningfully to Merck’s top line, somewhat making up for the generic competition for several drugs. In 2016, Keytruda brought in 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 in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. AMGN, Incyte, GlaxoSmithKline plc GSK and Pfizer Inc. PFE separately for the evaluation of Keytruda in combination with other regimens. The last few months saw a series of positive news on Keytruda, raising sales expectations for the drug. Further label expansion of the drug should significantly boost Merck’s top line.
In a separate press release, Merck announced that the FDA has extended the action date for the sBLA for Keytruda for previously treated patients with advanced microsatellite instability-high (MSI-H) cancer by three months.
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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