FDA clears efficacy supplement for Merck's Keytruda Qlex

The FDA approved supplement number 8 for KEYTRUDA QLEX, a combination injectable product from sponsor Merck Sharp Dohme, with a submission status date of October 16, 2026. The filing is classified as an efficacy supplement under application number BLA761467 and received a standard review priority.¹

The product combines pembrolizumab, the active ingredient also known by its brand name Keytruda, with berahyaluronidase alfa-pmph, an enzyme component used in subcutaneous formulations. The FDA record lists two injectable product strengths: one containing pembrolizumab at 790MG/9600UNITS in a 4.8ML presentation, and another at 395MG/4800UNITS in a 2.4ML presentation, both paired with berahyaluronidase alfa-pmph and delivered by injection.¹

The submission's status is listed as approved (AP) as of the October 16, 2026 date. The FDA's public drug approval database does not provide further detail in this record about the specific clinical data or indication changes associated with this efficacy supplement.

Keytruda Qlex represents a subcutaneous route for pembrolizumab delivery, pairing the checkpoint inhibitor with a hyaluronidase enzyme intended to facilitate subcutaneous administration. The record identifies Merck Sharp Dohme as the sponsor for this application.

No additional details on trial data, prior supplement history, or indication scope were included in the FDA Drugs@FDA record reviewed for this item.