The U.S. Food and Drug Administration (FDA) has approved a subcutaneous formulation of pembrolizumab, also known as Keytruda, marking a significant advancement in cancer treatment. Announced on September 19, 2025, this new method allows for a more convenient administration of the drug for both adults and pediatric patients aged 12 years and older suffering from various solid tumors.
Patients previously required intravenous (IV) administration of pembrolizumab, a treatment known for its efficacy in oncology. With the new subcutaneous option, patients can now receive their treatment in a significantly shorter time frame. According to J. Thaddeus Beck, MD, FACP, a medical oncologist at Highlands Oncology in Rogers, Arkansas, this change allows patients greater flexibility in managing their time outside the clinic.
Clinical Trial Success and Approval Details
The subcutaneous formulation was evaluated in the phase 3 trial Study MK-3475A-D77 (NCT05722015), which focused on patients with untreated, metastatic non-small cell lung cancer (NSCLC) without specific genomic aberrations. The trial compared the new subcutaneous method against the traditional IV administration. In total, 251 patients were randomly assigned to receive either subcutaneous pembrolizumab or IV pembrolizumab, administered every six weeks alongside platinum doublet chemotherapy.
Results indicated that the pharmacokinetic endpoints met the predefined acceptance margins. Specifically, the lower boundary of the 96% confidence interval for the first cycle’s area under the curve was above the threshold for comparability. Furthermore, the confirmed objective response rate was 45% in the subcutaneous group compared to 42% in the IV group, suggesting comparable efficacy. Progression-free survival and overall survival rates also showed no significant differences between the two methods.
Patient Experience and Future Implications
Dr. Beck emphasized the positive feedback from patients participating in the trial. He noted that the subcutaneous injection, which is approximately 2.4 mL in volume, can be administered in seconds rather than the 30 minutes typically required for IV treatments. This change significantly enhances the patient experience, allowing them to spend less time in treatment chairs and more time engaging in activities they enjoy.
“The approval of the subcutaneous form of pembrolizumab gives us another option that we can use to tailor treatments for patients’ individual situations,” Dr. Beck explained. He added that this new method not only improves patient satisfaction but also optimizes treatment facility resources by reducing chair time.
In preparation for implementing this new treatment option, Dr. Beck’s facility is adapting its infrastructure. The clinic plans to create a dedicated area for subcutaneous administration, allowing for a faster workflow and ensuring patient privacy during treatment. This strategic change highlights the growing trend towards more patient-centered care in oncology.
The approval of subcutaneous pembrolizumab signifies a pivotal shift in cancer treatment, offering both efficacy and convenience. As more monoclonal antibodies move towards subcutaneous administration, the landscape of oncology may evolve significantly, placing a greater emphasis on patient experience and operational efficiency in treatment settings.