A groundbreaking subcutaneous injection, KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), has been approved for Merck by the U.S. Food and Drug Administration (FDA). by the U.S. Food and Drug Administration (FDA).

The drug represents the first and only subcutaneously administered immune checkpoint inhibitor. This new formulation, which combines the active ingredient of KEYTRUDA® with a hyaluronidase enzyme to facilitate its quick administration, is approved for use across most of the existing solid tumor indications for intravenous (IV) KEYTRUDA.

A key benefit of KEYTRUDA QLEX is the convenience and speed of its administration; it can be given by a healthcare provider in as little as one minute every three weeks or two minutes every six weeks, a substantial reduction from the 30-minute IV infusion required for the original KEYTRUDA. This faster delivery allows for greater flexibility in treatment settings, potentially moving therapy from an infusion center to a doctor's office or a community-based clinic.

The approval of KEYTRUDA QLEX is supported by a pivotal Phase 3 trial comparing the subcutaneous version to IV KEYTRUDA in patients with metastatic non-small cell lung cancer. The study demonstrated comparable pharmacokinetic exposure, as well as similar overall response rates and no notable differences in progression-free survival or overall survival, confirming that the new formulation provides comparable efficacy to the established IV drug. However, as a fixed-combination drug product of pembrolizumab, KEYTRUDA QLEX carries the same significant safety warnings as its intravenous counterpart. It is contraindicated in patients with hypersensitivity to its components and comes with a risk of severe or fatal immune-mediated adverse reactions that can affect various organ systems, including pneumonitis, colitis, hepatitis, and endocrinopathies. The drug can also cause administration-related reactions and, due to its mechanism of action, can cause harm to a fetus if administered during pregnancy. Merck expects to make KEYTRUDA QLEX available in the U.S. in late September, offering patients a more convenient option for their cancer treatment.