Faster Shots for Cancer Care: Merck’s Keytruda Qlex Debuts

Merck’s subcutaneous Keytruda Qlex offers faster cancer dosing, though IV remains the mainstay for most patients.

8 Oct 2025

Merck has received U.S. Food and Drug Administration approval for a new injectable version of its cancer therapy Keytruda, designed to shorten dosing time and expand treatment options for eligible patients.

Approved on September 19, 2025, Keytruda Qlex combines pembrolizumab with berahyaluronidase alfa and allows health care providers to administer the drug under the skin in one to two minutes. The formulation is approved for adults and adolescents aged 12 or older with most of the same solid tumor indications as the intravenous (IV) version.

The new subcutaneous option is intended to complement, rather than replace, IV infusions. Administration will still require a clinical setting and trained personnel, and the IV route will remain standard for patients or conditions not suitable for the injectable form.

Merck said its clinical studies showed comparable drug exposure and efficacy between the subcutaneous and IV formulations when combined with chemotherapy. Time-and-motion analyses indicated a 45 to 50 per cent reduction in chair time and clinician workload for patients eligible for the injectable version.

Analysts said the launch could ease operational strain on oncology clinics and improve patient convenience, though widespread adoption may take time. Uptake will likely depend on payer coverage, provider acceptance, and local policy frameworks.

The move also strengthens Merck’s position as its top-selling immunotherapy faces potential biosimilar competition later this decade, when key patents on the IV formulation are due to expire. Still, the company faces hurdles in pricing, reimbursement, and integration into existing treatment pathways.

Several pharmaceutical groups are pursuing similar efforts to develop subcutaneous or hybrid delivery options for biologic drugs. However, few have reached comparable regulatory milestones.

Merck described Keytruda Qlex as part of its long-term effort to “enhance patient experience and treatment accessibility” while maintaining the established role of IV therapy. The broader impact of the injectable formulation, industry observers said, will depend on how quickly healthcare systems adapt to the shift toward faster, more flexible cancer care.