FDA Approves Merck's Subcutaneous KEYTRUDA QLEX for Solid Tumors
- FDA approved KEYTRUDA QLEX for subcutaneous use in adults with most solid tumors.
- KEYTRUDA QLEX combines pembrolizumab and berahyaluronidase alfa, developed by Alteogen Inc.
- Merck plans to release KEYTRUDA QLEX in the U.S. by late September.
- A trial showed similar efficacy between subcutaneous KEYTRUDA QLEX and IV KEYTRUDA in metastatic NSCLC.
FDA Approval
The U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX for subcutaneous administration in adults with most solid tumor indications. This new formulation combines pembrolizumab and berahyaluronidase alfa, a variant of human hyaluronidase developed by Alteogen Inc.
Administration and Availability
KEYTRUDA QLEX is the first subcutaneously administered immune checkpoint inhibitor that can be given by a healthcare provider in as little as one minute. Merck plans to make it available in the U.S. by late September.
Clinical Trial Results
A pivotal trial compared subcutaneous KEYTRUDA QLEX to intravenous KEYTRUDA, both administered every six weeks with chemotherapy, in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) without EGFR, ALK, or ROS1 genomic tumor aberrations. The trial demonstrated comparable pharmacokinetic exposure levels to pembrolizumab, with similar overall response rates between the two formulations.
Source: Merck