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Merck's (MRK) Keytruda Gets Nod for Esophageal Cancer in EU (Revised)
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Merck & Co. (MRK - Free Report) announced that the European Commission has granted approval to its PD-L1 inhibitor, Keytruda in Europe as a first-line treatment in combination with chemotherapy for certain patients with esophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
Following the nod, Keytruda became the first anti-PD-1 therapy in Europe to be approved in combination with platinum- and fluoropyrimidine-based chemotherapy in first-line setting for advanced esophageal and HER2-negative GEJ cancer.
The European approval was based on results from the pivotal phase III KEYNOTE-590 study. In the study, Keytruda plus platinum- and fluoropyrimidine-based chemotherapy significantly improved overall survival by reducing the risk of death by 27% versus chemotherapy. The combination also significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 35%.
Keytruda was approved for a similar indication by the FDA in March.
Merck’s stock has declined 5.6% this year so far against an increase of 8.2% for the industry.
Image Source: Zacks Investment Research
Keytruda is a key top-line driver for Merck as it is approved for treatment of many cancers globally. The drug generated sales of $3.9 billion in the first quarter of 2021, up 16% (excluding Fx impact) year over year.
Keytruda is continuously growing and expanding into new indications and markets globally. In fact, the Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1500 studies, including more than 1050 combination studies. Merck has collaborated with several companies including Amgen (AMGN - Free Report) , Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda has strong growth prospects based on increased utilization, approval for new indications and expectation of additional approvals worldwide. Though Keytruda may be Merck’s biggest strength and a solid reason to own the stock, it can also be argued that the company is excessively dependent on the drug and should look for ways to diversify its product lineup.
Image: Shutterstock
Merck's (MRK) Keytruda Gets Nod for Esophageal Cancer in EU (Revised)
Merck & Co. (MRK - Free Report) announced that the European Commission has granted approval to its PD-L1 inhibitor, Keytruda in Europe as a first-line treatment in combination with chemotherapy for certain patients with esophageal cancer or HER2-negative gastroesophageal junction (GEJ) adenocarcinoma in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
Following the nod, Keytruda became the first anti-PD-1 therapy in Europe to be approved in combination with platinum- and fluoropyrimidine-based chemotherapy in first-line setting for advanced esophageal and HER2-negative GEJ cancer.
The European approval was based on results from the pivotal phase III KEYNOTE-590 study. In the study, Keytruda plus platinum- and fluoropyrimidine-based chemotherapy significantly improved overall survival by reducing the risk of death by 27% versus chemotherapy. The combination also significantly improved progression-free survival (PFS), reducing the risk of disease progression or death by 35%.
Keytruda was approved for a similar indication by the FDA in March.
Merck’s stock has declined 5.6% this year so far against an increase of 8.2% for the industry.
Keytruda is a key top-line driver for Merck as it is approved for treatment of many cancers globally. The drug generated sales of $3.9 billion in the first quarter of 2021, up 16% (excluding Fx impact) year over year.
Keytruda is continuously growing and expanding into new indications and markets globally. In fact, the Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1500 studies, including more than 1050 combination studies. Merck has collaborated with several companies including Amgen (AMGN - Free Report) , Glaxo (GSK - Free Report) and Pfizer (PFE - Free Report) , separately, for the evaluation of Keytruda in combination with other regimens.
Undoubtedly, Keytruda has strong growth prospects based on increased utilization, approval for new indications and expectation of additional approvals worldwide. Though Keytruda may be Merck’s biggest strength and a solid reason to own the stock, it can also be argued that the company is excessively dependent on the drug and should look for ways to diversify its product lineup.
Merck currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
(We are reissuing this article to correct a mistake. The original article, issued on June 30, 2021, should no longer be relied upon.)