Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

Shots: The EC has approved Keytruda SC (pembrolizumab & berahyaluronidase alfa-pmph) for SC dosing in adults across all 33 Keytruda indications in all 30 EEA states, with availability subject to multiple factors, incl. national reimbursement processes Approval was based on P-III (3475A-D77) trial assessing Keytruda SC (790mg/9600 units, Q6W; n=251) vs IV Keytruda (400mg, Q6W;…

ByRidhi RastogiNovember 20, 2025

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…

ByRidhi RastogiSeptember 22, 2025

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

Shots: The P-III (3475A-D77) trial assessed SC Keytruda (Q6W) + berahyaluronidase alfa + CT vs IV Keytruda (Q6W) + CT in 1L metastatic NSCLC adults (n=377), regardless of PD-L1 TPS expression; BLA under the US FDA’s review (PDUFA: Sep 23, 2025) & MAA under EMA’s review Trial showed that SC is noninferior to IV in AUC…

ByRidhi RastogiMarch 28, 2025

Merck’s Keytruda SC Receives the EC Approval for Subcutaneous Use Across 33 Solid Tumor Indications for Keytruda

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

Merck Presents P-III (3475A-D77) Trial Data of SC Keytruda for NSCLC at ELCC 2025

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