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Merck (MRK) Gets FDA's Priority Review for Another Keytruda sBLA
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Merck & Co., Inc. (MRK - Free Report) announced that that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of its blockbuster anti-PD-1 therapy, Keytruda, for newly diagnosed esophageal and gastroesophageal junction (“GEJ”) cancer. The company is seeking an approval for Keytruda in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable/metastatic esophageal and GEJ cancer.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Apr 13, 2021.
The sBLA was based on data from the pivotal phase III KEYNOTE-590 study which evaluated Keytruda plus chemotherapy for treating esophagus and GEJ cancer in the first-line setting. Data from the study showed that treatment with the Keytruda combo led to significant improvements in overall survival and progression-free survival – the primary endpoints, as compared to patients who received only chemotherapy regardless of their PD-L1 expression status and tumor histology.
Per the company, despite current available treatments, patients with esophageal and GEJ cancer in the first-line setting often face an aggressive disease with a poor prognosis. If approved, the Keytruda combo can become a new treatment option for the given patient population.
Notably, Keytruda as a monotherapy is already approved for the second-line treatment of recurrent locally advanced/metastatic squamous cell carcinoma of the esophagus in patients whose tumors express PD-L1 in the United States, China and Japan.
Shares of Merck have declined 12.2% so far this year against the industry’s increase of 2.2%.
Merck’s biggest product, Keytruda, is already approved for treating 30 indications across several different tumor types in the United States. The drug recorded sales of $10.4 billion in the first nine months of 2020, up 30.3% year over year, driven by continuous label expansion into various new indications.
We note that the Keytruda development program is also progressing well with Merck, spending billions of dollars on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1300 studies including 900 plus combination studies. Meanwhile, Merck has collaborated with several companies including Glaxo (GSK - Free Report) , Amgen (AMGN - Free Report) , Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Bigstock
Merck (MRK) Gets FDA's Priority Review for Another Keytruda sBLA
Merck & Co., Inc. (MRK - Free Report) announced that that the FDA has accepted its supplemental biologics license application (sBLA) seeking approval of its blockbuster anti-PD-1 therapy, Keytruda, for newly diagnosed esophageal and gastroesophageal junction (“GEJ”) cancer. The company is seeking an approval for Keytruda in combination with platinum and fluoropyrimidine-based chemotherapy for the first-line treatment of patients with locally advanced unresectable/metastatic esophageal and GEJ cancer.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body is expected on Apr 13, 2021.
The sBLA was based on data from the pivotal phase III KEYNOTE-590 study which evaluated Keytruda plus chemotherapy for treating esophagus and GEJ cancer in the first-line setting. Data from the study showed that treatment with the Keytruda combo led to significant improvements in overall survival and progression-free survival – the primary endpoints, as compared to patients who received only chemotherapy regardless of their PD-L1 expression status and tumor histology.
Per the company, despite current available treatments, patients with esophageal and GEJ cancer in the first-line setting often face an aggressive disease with a poor prognosis. If approved, the Keytruda combo can become a new treatment option for the given patient population.
Notably, Keytruda as a monotherapy is already approved for the second-line treatment of recurrent locally advanced/metastatic squamous cell carcinoma of the esophagus in patients whose tumors express PD-L1 in the United States, China and Japan.
Shares of Merck have declined 12.2% so far this year against the industry’s increase of 2.2%.
Merck’s biggest product, Keytruda, is already approved for treating 30 indications across several different tumor types in the United States. The drug recorded sales of $10.4 billion in the first nine months of 2020, up 30.3% year over year, driven by continuous label expansion into various new indications.
We note that the Keytruda development program is also progressing well with Merck, spending billions of dollars on research and development of this medicine to secure more approvals in earlier lines of treatment. The drug is being studied for more than 30 types of cancer in over 1300 studies including 900 plus combination studies. Meanwhile, Merck has collaborated with several companies including Glaxo (GSK - Free Report) , Amgen (AMGN - Free Report) , Pfizer (PFE - Free Report) separately for the evaluation of Keytruda in combination with other regimens.
Zacks Rank
Merck currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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