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WASHINGTON - The U.S. Food and Drug Administration said it has approved a new formulation of Merck's cancer therapy Keytruda that can be administered under the skin, offering a more convenient version of the widely used cancer immunotherapy.
The latest announcement could provide added convenience and potentially improve a patient’s experience.
Keytruda Qlex gets FDA approval
The new version, called Keytruda Qlex, is an injection that can be administered in as little as a minute or two depending on dosage, compared to IV infusion that typically takes about 30 minutes.
Signage outside Merck & Co. headquarters in Kenilworth, New Jersey, U.S., on Monday, Jan. 25, 2021. (Credit: Christopher Occhicone/Bloomberg via Getty Images)
The injection can also be administered by healthcare professionals in multiple settings, from an infusion center to a doctor’s office or a local community-based clinic.
In addition, this new version also offers a choice of injection site in the thigh or abdomen, avoiding the area around the navel. For patients who do not require a port or whose veins are difficult to access, subcutaneous administration may simplify treatment administration.
What they're saying:
"This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers. We now have a new option with a broad set of indications that has demonstrated comparability with intravenous (IV) pembrolizumab but in a subcutaneous injection that can be administered in one minute every three weeks or two minutes every six weeks," Dr. J. Thaddeus Beck, an oncologist and medical director of the Highlands’ Clinical Trials Office, said in a statement. "Subcutaneous pembrolizumab provides faster administration than IV pembrolizumab, offers two dosing options and gives patients more choices of health care settings in which they can receive their therapy."
New version found to be effective in clinical trials
The backstory:
Keytruda was first approved in 2014 and is used to treat multiple types of cancer. According to Reuters, it generated nearly $30 billion in global sales last year.
In clinical trials comparing the old and new versions of the drug, the new version Keytruda Qlex was shown to be no less effective than its IV formulation with similar overall response rates.
"At Merck, we are committed to putting patients first, as we work relentlessly to discover new options that may help patients manage their treatment in a way that fits their needs," said Dr. Marjorie Green, the senior vice president and head of oncology, global clinical development, at Merck Research Laboratories.
When will Keytruda Qlex be availabe?
What's next:
Merck expects to have Keytruda Qlex available in the U.S. in late September.
The Source: The information for this story was provided by a press release by Merck published on Sept. 19, 2025. Reuters also contributed. This story was reported from Los Angeles.