n a development that could meaningfully alter patient experience and clinic workflows for a broad set of oncology patients, the U.S. Food and Drug Administration on September 19 approved a subcutaneous (under-the-skin) formulation of pembrolizumab branded Keytruda Qlex that reduces administration time from the typical half-hour intravenous infusion to a one-to-two-minute injection depending on dose; regulators concluded the new formulation’s safety and efficacy profile is comparable to the longstanding IV product while offering clear convenience benefits that may improve clinic throughput and patient comfort, particularly for older patients who often find repeated long infusions taxing and travel-challenging.

This approval follows a global trend among pharmaceutical companies toward subcutaneous versions of monoclonal antibodies and immune checkpoint inhibitors to hold market share amid rising biosimilar competition; Merck expects the new formulation to be available in the United States late this month and projects it could account for a sizable fraction of Keytruda use within a couple years, underscoring both commercial strategy and a practical shift in how cancer care is delivered in outpatient settings. Clinicians will now evaluate when and for whom the subcutaneous option is most appropriate balancing site-of-care considerations, patient preference, and specific tumor-type indications and clinics should prepare operational changes (e.g., shorter chair time, scheduling, and storage logistics) while payers and policymakers consider how reimbursement frameworks will adapt. For older adults in particular, the new formulation removes one common barrier to treatment adherence long infusion sessions and could reduce the ancillary burdens that accompany frequent hospital visits, though long-term comparative effectiveness in real-world practice will need monitoring as uptake increases.