Please ensure Javascript is enabled for purposes of website accessibility

FDA Rejects New Dosing for Merck's Cancer Drug Keytruda

By Brian Orelli, PhD – Feb 19, 2020 at 2:34PM

You’re reading a free article with opinions that may differ from The Motley Fool’s Premium Investing Services. Become a Motley Fool member today to get instant access to our top analyst recommendations, in-depth research, investing resources, and more. Learn More

The old dosing regimen will still be available for patients.

Merck (MRK 0.23%) on Tuesday received a complete response letter (CRL) from the Food and Drug Administration for a new dosing regimen for its cancer blockbuster Keytruda. A CRL is the FDA's euphemism for a rejection letter, although companies can reapply for approval if they generate more data.

The big pharma didn't disclose what information the agency is looking for regarding Keytruda, and only noted that it's "reviewing the letter and will discuss next steps with the FDA."

Rejected stamp

Image source: Getty Images.

Merck had applied for approval to offer Keytruda in a regimen of 400 mg doses every six weeks for patients with six different types of cancer: melanoma, classical Hodgkin lymphoma, primary mediastinal large B-cell lymphoma, gastric cancer, hepatocellular carcinoma, and Merkel cell carcinoma. The immunotherapy is currently approved for those cancers at a dose of 200 mg every three weeks. The new dosing regimen would have given patients more flexibility and reduced the number of trips they have to make to get their medication infused.

The applications were based on pharmacokinetic modeling and simulation data, which estimates the amount of a drug in the patient over time based on absorption, distribution, metabolism and excretion rates. European regulators approved the 400 mg dosing regimen based on the same data last year.

PD-1 is a protein found on the surface of immune cells that helps them identify which unhealthy cells to attack, but cancer cells can use that mechanism to trick the immune cells into ignoring tumors. Keytruda  blocks the interaction that allows those cancer cells to hide, enabling the immune system to detect and fight them.

Brian Orelli and The Motley Fool have no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

Invest Smarter with The Motley Fool

Join Over 1 Million Premium Members Receiving…

  • New Stock Picks Each Month
  • Detailed Analysis of Companies
  • Model Portfolios
  • Live Streaming During Market Hours
  • And Much More
Get Started Now

Stocks Mentioned

Merck & Co., Inc. Stock Quote
Merck & Co., Inc.
MRK
$87.64 (0.23%) $0.20

*Average returns of all recommendations since inception. Cost basis and return based on previous market day close.

Related Articles

Motley Fool Returns

Motley Fool Stock Advisor

Market-beating stocks from our award-winning analyst team.

Stock Advisor Returns
338%
 
S&P 500 Returns
108%

Calculated by average return of all stock recommendations since inception of the Stock Advisor service in February of 2002. Returns as of 10/07/2022.

Discounted offers are only available to new members. Stock Advisor list price is $199 per year.

Premium Investing Services

Invest better with The Motley Fool. Get stock recommendations, portfolio guidance, and more from The Motley Fool's premium services.