The U.S. Food and Drug Administration (FDA) on Friday approved Merck & Co. Inc.’s (NYSE:MRK) Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for Keytruda.
Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc.
Merck expects to have Keytruda Qlex available in the U.S. in late September.
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The pivotal trial comparing subcutaneous Keytruda Qlex to IV Keytruda administered every six weeks, each with chemotherapy, was conducted in patients with treatment-naïve metastatic non-small cell lung cancer (NSCLC) with no EGFR, ALK, or ROS1 genomic tumor aberrations.
In descriptive efficacy analyses, overall response rates (ORR) were similar between Keytruda Qlex and Keytruda (45% vs. 42%). Additionally, no notable differences were observed in progression-free survival (PFS) and overall survival (OS).
The effectiveness of Keytruda Qlex for its approved indications was established based on these data and pivotal trial data demonstrating comparable safety with Keytruda, as well as evidence from adequate and well-controlled studies conducted with Keytruda.
As a subcutaneous injection, Keytruda Qlex may provide added convenience compared to IV Keytruda. It can be given in one minute every three weeks or in two minutes every six weeks, requiring substantially less time to administer than a 30-minute IV infusion of Keytruda.
On Friday, the European agency recommended approval for two positive opinions for Keytruda, including a new subcutaneous administration route.
Price Action: MRK stock is trading lower by 1.23% to $80.51 at last check Monday.
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