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FDA Approves Quick-Inject Cancer Therapy Keytruda Qlex

9/23/2025

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Summary

Story summary

U.S. Food and Drug Administration approves Merck's Keytruda Qlex, a subcutaneous cancer therapy, on September 22, 2025.
Keytruda Qlex can be injected in 1-2 minutes, with flexible administration across settings.
Trials show efficacy and safety comparable to the IV form.
Merck expects 30-40% to switch within 18-24 months; U.S. availability by late September 2025, covering 38 Keytruda indications.

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Story summary

U.S. Food and Drug Administration approves Merck's Keytruda Qlex, a subcutaneous cancer therapy, on September 22, 2025.
Keytruda Qlex can be injected in 1-2 minutes, with flexible administration across settings.
Trials show efficacy and safety comparable to the IV form.
Merck expects 30-40% to switch within 18-24 months; U.S. availability by late September 2025, covering 38 Keytruda indications.