We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Merck (MRK) to Withdraw a Gastric Cancer Indication for Keytruda
Read MoreHide Full Article
Merck (MRK - Free Report) is set to withdraw the indication of third or later-line treatment of advanced gastric cancer for its blockbuster immuno-oncology drug, Keytruda, in the United States. Following a discussion with the FDA the company has planned to initiate the withdrawal in six months.
We remind investors that Keytruda was granted accelerated approval in 2017 as monotherapy for treating recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (combined positive score of 1 or more) in patients whose disease has progressed following two or more prior lines of chemotherapies.
The continued approval for this indication was contingent upon results of a phase III study as a post-marketing requirement. This late-stage study did not meet its primary endpoint of overall survival benefit in the recurrent gastric cancer indication.
As a result, Merck announced voluntary withdrawal of the drug for the aforementioned indication following evaluation by the Oncologic Drugs Advisory Committee and in consultation with the FDA. However, the drug’s accelerated approval for first-line treatment of gastric cancer in combination with Roche’s (RHHBY - Free Report) Herceptin and chemotherapies, granted earlier this year, remains unaffected. This withdrawal does not impact any other approved indications for the drug.
Meanwhile, the company is also developing the drug for treating gastric cancer in different treatment settings, including first-line, neoadjuvant and adjuvant treatment setting.
Shares of Merck have declined 4.7% so far this year against the industry’s increase of 8.3%.
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% 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, separately, for the evaluation of Keytruda in combination with other regimens.
With continued label expansions and several ongoing label-expansion studies, the drug has a strong growth prospect. However, Merck is excessively dependent on the drug.
Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.
Image: Shutterstock
Merck (MRK) to Withdraw a Gastric Cancer Indication for Keytruda
Merck (MRK - Free Report) is set to withdraw the indication of third or later-line treatment of advanced gastric cancer for its blockbuster immuno-oncology drug, Keytruda, in the United States. Following a discussion with the FDA the company has planned to initiate the withdrawal in six months.
We remind investors that Keytruda was granted accelerated approval in 2017 as monotherapy for treating recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (combined positive score of 1 or more) in patients whose disease has progressed following two or more prior lines of chemotherapies.
The continued approval for this indication was contingent upon results of a phase III study as a post-marketing requirement. This late-stage study did not meet its primary endpoint of overall survival benefit in the recurrent gastric cancer indication.
As a result, Merck announced voluntary withdrawal of the drug for the aforementioned indication following evaluation by the Oncologic Drugs Advisory Committee and in consultation with the FDA. However, the drug’s accelerated approval for first-line treatment of gastric cancer in combination with Roche’s (RHHBY - Free Report) Herceptin and chemotherapies, granted earlier this year, remains unaffected. This withdrawal does not impact any other approved indications for the drug.
Meanwhile, the company is also developing the drug for treating gastric cancer in different treatment settings, including first-line, neoadjuvant and adjuvant treatment setting.
Shares of Merck have declined 4.7% so far this year against the industry’s increase of 8.3%.
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% 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, separately, for the evaluation of Keytruda in combination with other regimens.
With continued label expansions and several ongoing label-expansion studies, the drug has a strong growth prospect. However, Merck is excessively dependent on the drug.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank
Merck currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Zacks' Top Picks to Cash in on Artificial Intelligence
In 2021, this world-changing technology is projected to generate $327.5 billion in revenue. Now Shark Tank star and billionaire investor Mark Cuban says AI will create "the world's first trillionaires." Zacks' urgent special report reveals 3 AI picks investors need to know about today.
See 3 Artificial Intelligence Stocks With Extreme Upside Potential>>