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's (MRK) Keytruda Gets FDA Nod for Solid Tumor Cancers
Read MoreHide Full Article
Merck & Co., Inc. (MRK - Free Report) announced that its anti-PD-1 therapy, Keytruda, has received accelerated approval for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. Also, the label will be expanded to include MSI-H or mismatch repair deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
In a separate press release, Merck announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) for label expansion of Keytruda for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma. The FDA is expected to give its decision on Sep 22.
Presently, Keytruda is approved in the U.S. and EU 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. In the U.S. it is also approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).
Merck’s shares are up 9.8% year to date, comparing unfavorably with an increase of 10.2% witnessed by the Zacks classified Large-Cap Pharma industry.
The last few months witnessed a series of regulatory approvals for label expansion of Keytruda that should drive sales going forward. Keytruda brought in sales of $584 million in first-quarter 2017, up 20.9% sequentially and 134.5% year over year.
Earlier this month, the company announced that FDA has approved two new bladder cancer indications for Keytruda. Also, this month, the FDA granted accelerated approval to Keytruda for use in combination with Eli Lilly & Company’s (LLY - Free Report) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo), a commonly used chemo regimen, for the first-line treatment of metastatic NSCLC, irrespective of PD-L1 expression. Note that this is the first FDA approval for Keytruda as combination therapy.
In Mar/Apr 2017, Keytruda received FDA and EU approval for refractory classical Hodgkin lymphoma (cHL) - the first Keytruda approval for hematologic malignancy indication.
Keytruda is the first anti-PD-1 therapy to gain FDA approval and is continuously growing and expanding into new indications and markets globally. Especially, its sales received a boost with the approval in the first-line lung cancer setting. With the recent label expansions, sales should pick up further in the upcoming quarters.
Meanwhile, Keytruda is being studied for more than 30 types of cancer in 500 trials. Almost 50% of these trials are in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) ) and Pfizer separately for the evaluation of Keytruda in combination with other regimens
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>
Unique Zacks Analysis of Your Chosen Ticker
Pick one free report - opportunity may be withdrawn at any time
Image: Bigstock
Merck's (MRK) Keytruda Gets FDA Nod for Solid Tumor Cancers
Merck & Co., Inc. (MRK - Free Report) announced that its anti-PD-1 therapy, Keytruda, has received accelerated approval for the treatment of microsatellite instability-high (MSI-H) or mismatch repair deficient solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options. Also, the label will be expanded to include MSI-H or mismatch repair deficient colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.
In a separate press release, Merck announced that the FDA has granted priority review to its supplemental biologics license application (sBLA) for label expansion of Keytruda for the treatment of recurrent or advanced gastric or gastroesophageal junction adenocarcinoma. The FDA is expected to give its decision on Sep 22.
Presently, Keytruda is approved in the U.S. and EU 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. In the U.S. it is also approved for previously treated recurrent or metastatic head and neck cancer (HNSCC).
Merck’s shares are up 9.8% year to date, comparing unfavorably with an increase of 10.2% witnessed by the Zacks classified Large-Cap Pharma industry.
The last few months witnessed a series of regulatory approvals for label expansion of Keytruda that should drive sales going forward. Keytruda brought in sales of $584 million in first-quarter 2017, up 20.9% sequentially and 134.5% year over year.
Earlier this month, the company announced that FDA has approved two new bladder cancer indications for Keytruda. Also, this month, the FDA granted accelerated approval to Keytruda for use in combination with Eli Lilly & Company’s (LLY - Free Report) cancer drug Alimta (pemetrexed) and carboplatin (pem/carbo), a commonly used chemo regimen, for the first-line treatment of metastatic NSCLC, irrespective of PD-L1 expression. Note that this is the first FDA approval for Keytruda as combination therapy.
In Mar/Apr 2017, Keytruda received FDA and EU approval for refractory classical Hodgkin lymphoma (cHL) - the first Keytruda approval for hematologic malignancy indication.
Keytruda is the first anti-PD-1 therapy to gain FDA approval and is continuously growing and expanding into new indications and markets globally. Especially, its sales received a boost with the approval in the first-line lung cancer setting. With the recent label expansions, sales should pick up further in the upcoming quarters.
Meanwhile, Keytruda is being studied for more than 30 types of cancer in 500 trials. Almost 50% of these trials are in combination with other cancer drugs. Merck is collaborating with several companies including Amgen, Inc. (AMGN - Free Report) , Incyte, GlaxoSmithKline plc (GSK - Free Report) ) and Pfizer separately for the evaluation of Keytruda in combination with other regimens
Merck carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Looking for Stocks with Skyrocketing Upside?
Zacks has just released a Special Report on the booming investment opportunities of legal marijuana. Ignited by new referendums and legislation, this industry is expected to blast from an already robust $6.7 billion to $20.2 billion in 2021. Early investors stand to make a killing, but you have to be ready to act and know just where to look. See the pot trades we're targeting>>