FDA approves Keytruda Qlex, a subcutaneous injection version of the widely used cancer therapy Keytruda
Patients can now receive treatment in as little as one to two minutes, compared to a 30-minute IV infusion
New option offers greater convenience and flexibility in treatment settings, from hospitals to local clinics
The U.S. Food and Drug Administration (FDA) has approved Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), a new subcutaneous form of Merck’s flagship cancer immunotherapy Keytruda. This marks the first time patients across most of Keytruda’s 38 cancer indications will have access to the drug in an injection form rather than an intravenous (IV) infusion.
Keytruda Qlex can be administered by a healthcare provider in just one minute every three weeks or two minutes every six weeks. That’s a major time savings compared to the 30-minute IV infusion required for traditional Keytruda.
“This approval is significant for patients and health care providers like me who have been using immunotherapies for years to treat certain cancers,” said Dr. J. Thaddeus Beck, oncologist and medical director of the Highlands’ Clinical Trials Office. “Subcutaneous pembrolizumab provides faster administration, two dosing options, and more choices for where patients can receive care.”
Comparable effectiveness and safety
In pivotal clinical trials, Keytruda Qlex showed similar effectiveness and safety compared to IV Keytruda. Patients with advanced lung cancer who received the injection saw response rates and survival outcomes nearly identical to those receiving the infusion.
The new formulation was developed with the help of biotechnology company Alteogen Inc., whose enzyme allows pembrolizumab to be delivered under the skin instead of through a vein.
For patients who struggle with vein access or who don’t have a port in place, the subcutaneous injection may simplify treatment. It also gives patients and providers more flexibility in choosing where treatment takes place, whether in a hospital infusion center, a doctor’s office, or a community clinic.
“This is about giving patients options and helping them manage treatment in a way that best fits their needs,” said Dr. Marjorie Green, senior vice president and head of oncology at Merck Research Laboratories.
Safety considerations
As with IV Keytruda, Keytruda Qlex carries risks of serious immune-related side effects, which may affect organs such as the lungs, liver, or kidneys, and in rare cases can be life-threatening.
It is not recommended for certain patients, including those with hypersensitivity to its components or pregnant women due to potential risks to the fetus. Patients are encouraged to discuss the benefits and risks with their healthcare team.
Merck expects Keytruda Qlex to be available in the United States in late September. Patients and caregivers can ask their oncologists if the new injection option is right for them.
