CMS TransmittalOncology

FDA Approval: KEYTRUDA QLEX (PEMBROLIZUMAB AND BERAHYALURONIDASE ALFA-PMPH) — Type 1 - New Molecular Entity

FDA-BLA761467

Document details

Document type
CMS Transmittal
Issuing body
Centers for Medicare & Medicaid Services
Document ID
FDA-BLA761467
Published
June 17, 2026
Effective date
September 19, 2025
MAC region
National

Summary

KEYTRUDA QLEX, an injectable drug approved under BLA761467, will be billed under Part B. Billing teams should verify the specific J-code upon FDA label publication.

New injectable KEYTRUDA QLEX offers promising treatment options.

Affected specialty

Oncology alerts →

Source document

http://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761467s000lblOrig1.pdf

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