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Merck's (MRK) Keytruda Gets Nod for Expanded Use in China
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Merck & Co. (MRK - Free Report) announced that China’s regulatory authority has granted approval to its PD-L1 inhibitor, Keytruda as a first-line treatment in combination with chemotherapy for patients with locally advanced unresectable or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma.
Following the nod, Keytruda becomes the first anti-PD-1 therapy in China to be approved in the first-line setting for advanced esophageal or GEJ cancer, irrespective of histology or PD-L1 expression. In China, esophageal cancer is the fifth most commonly diagnosed cancer.
Keytruda was approved for a similar indication by the FDA in March and received approval in Europe in June.
The 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%.
With the approval for first-line esophageal and GEJ cancer, Keytruda is now approved for two indications in esophageal cancer in China. It is already approved in China as a second-line treatment of certain patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
Keytruda is now approved for eight indications across five different types of cancers in China.
Merck’s stock has declined 7.1% this year so far against an increase of 15.5% for the industry.
Image Source: Zacks Investment Research
Keytruda is a key top-line driver for Merck as it is approved for the treatment of many cancers globally. The drug generated sales of $4.18 billion in the second quarter of 2021, up 20% (excluding Fx impact) year over year.
Keytruda is continuously growing and expanding into new indications and markets globally. The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1550 studies, including more than 1100 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 maybe 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: Bigstock
Merck's (MRK) Keytruda Gets Nod for Expanded Use in China
Merck & Co. (MRK - Free Report) announced that China’s regulatory authority has granted approval to its PD-L1 inhibitor, Keytruda as a first-line treatment in combination with chemotherapy for patients with locally advanced unresectable or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma.
Following the nod, Keytruda becomes the first anti-PD-1 therapy in China to be approved in the first-line setting for advanced esophageal or GEJ cancer, irrespective of histology or PD-L1 expression. In China, esophageal cancer is the fifth most commonly diagnosed cancer.
Keytruda was approved for a similar indication by the FDA in March and received approval in Europe in June.
The 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%.
With the approval for first-line esophageal and GEJ cancer, Keytruda is now approved for two indications in esophageal cancer in China. It is already approved in China as a second-line treatment of certain patients with locally advanced or metastatic esophageal squamous cell carcinoma whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10).
Keytruda is now approved for eight indications across five different types of cancers in China.
Merck’s stock has declined 7.1% this year so far against an increase of 15.5% for the industry.
Image Source: Zacks Investment Research
Keytruda is a key top-line driver for Merck as it is approved for the treatment of many cancers globally. The drug generated sales of $4.18 billion in the second quarter of 2021, up 20% (excluding Fx impact) year over year.
Keytruda is continuously growing and expanding into new indications and markets globally. The Keytruda development program is also progressing well and the drug is being studied for more than 30 types of cancer in more than 1550 studies, including more than 1100 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 maybe 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 #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.