U.S. markets open in 25 minutes
  • S&P Futures

    3,838.50
    -0.50 (-0.01%)
     
  • Dow Futures

    31,576.00
    +111.00 (+0.35%)
     
  • Nasdaq Futures

    12,585.50
    -78.25 (-0.62%)
     
  • Russell 2000 Futures

    2,209.50
    +19.80 (+0.90%)
     
  • Crude Oil

    65.91
    -0.18 (-0.27%)
     
  • Gold

    1,688.40
    -10.10 (-0.59%)
     
  • Silver

    25.19
    -0.09 (-0.36%)
     
  • EUR/USD

    1.1876
    -0.0048 (-0.40%)
     
  • 10-Yr Bond

    1.5980
    +0.0440 (+2.83%)
     
  • Vix

    26.27
    -2.30 (-8.05%)
     
  • GBP/USD

    1.3849
    +0.0021 (+0.15%)
     
  • USD/JPY

    108.7070
    +0.3250 (+0.30%)
     
  • BTC-USD

    50,968.95
    +208.18 (+0.41%)
     
  • CMC Crypto 200

    1,028.87
    +85.70 (+9.09%)
     
  • FTSE 100

    6,640.46
    +9.94 (+0.15%)
     
  • Nikkei 225

    28,743.25
    -121.07 (-0.42%)
     

Merck (MRK) Keytruda Gets CHMP Nod for First-Line Colon Cancer

  • Oops!
    Something went wrong.
    Please try again later.
Zacks Equity Research
·3 min read
  • Oops!
    Something went wrong.
    Please try again later.

Merck & Co., Inc. MRK announced that the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) issued a positive opinion to the Marketing Authorization Application (“MAA”) for its blockbuster drug, Keytruda for expanded use. The MAA seeks label expansion of the drug as first-line treatment of unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer.

A final decision from the European Commission on the MAA is expected in the first quarter of 2021.

Please note that the FDA had granted approval for a similar label expansion of the drug in June. Keytruda is already approved to treat MSI-H or dMMR colorectal cancer in patients whose cancer has progressed following treatment with fluoropyrimidine, oxaliplatin, and irinotecan. Until now, for treating first-line unresectable or metastatic MSI-H colorectal cancer, chemotherapy containing regimens were the only treatment options available in Europe. The approval of Keytruda provides a new monotherapy treatment option for this patient population.

The positive CHMP opinion was based on data from the phase III KEYNOTE-177 study, which showed that Keytruda significantly reduced the risk of disease progression or death by 40%, compared to the current standard-of-care chemotherapy regimen in the above patient population. In the study, the median progression-free survival was 16.5 months, more than double of 8.2 months for chemotherapy.

Merck’s shares have lost 8.8% this year so far against the industry’s 4.2% increase.

Keytruda, Merck’s major revenue generating product, is already approved for use in more than 30 indications across several different tumor types in the United States.

Keytruda recorded sales of $10.4 billion in the first nine months of 2020, up 30% year over year. The drug’s sales were driven by the launch of new indications globally, particularly from strong momentum in the first-line lung cancer indication.

The Keytruda development program is also progressing well with Merck spending billions 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. Merck has collaborated with several companies including Amgen AMGN, Incyte, Glaxo GSK and Pfizer PFE separately for the evaluation of Keytruda in combination with other regimens.

Merck & Co., Inc. Price

Merck & Co., Inc. Price
Merck & Co., Inc. Price

Merck & Co., Inc. price | Merck & Co., Inc. Quote

Zacks Rank

Merck currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

The Hottest Tech Mega-Trend of All

Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.

See Zacks' 3 Best Stocks to Play This Trend >>


Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
 
Pfizer Inc. (PFE) : Free Stock Analysis Report
 
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
 
GlaxoSmithKline plc (GSK) : Free Stock Analysis Report
 
Amgen Inc. (AMGN) : Free Stock Analysis Report
 
To read this article on Zacks.com click here.
 
Zacks Investment Research