Merck’s Keytruda Qlex Receives the US FDA’s Approval for Subcutaneous Use Across 38 Solid Tumor Indications for Keytruda

Shots:

• The US FDA has approved Keytruda Qlex (pembrolizumab & berahyaluronidase alfa-pmph) for subcutaneous dosing in adults across 38 approved indications of Keytruda, with US availability expected by late Sep 2025
• Approval was based on P-III (3475A-D77) trial assessing Keytruda Qlex (790mg/9600 units, Q6W) + Pt doublet CT vs IV Keytruda (400mg, Q6W) + Pt doublet CT in 1L metastatic NSCLC adults (n=377) with no EGFR, ALK or ROS1 mutations
• Trial showed that Keytruda Qlex is noninferior to Keytruda in AUC exposure & Ctrough, plus achieved ORR of 45% vs 42%, with comparable PFS & OS observed between the two

Ref: Merck  | Image: Merck | ⁠Press Release

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