← FDA DRUG APPROVALS

FDA BLA · BLA761467

KEYTRUDA QLEX

pembrolizumab and berahyaluronidase alfa-pmph

Sponsor: MERCK SHARP DOHME

APPLICATION
BLA761467
TYPE
BLA
ORIGINAL APPROVAL
2025-09-19
LATEST ACTION
2026-07-10
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

KEYTRUDA QLEXPrescription
PEMBROLIZUMAB 790MG/9600UNITS(4.8ML), BERAHYALURONIDASE ALFA-PMPH · INJECTABLE · INJECTION
KEYTRUDA QLEXPrescription
PEMBROLIZUMAB 395MG/4800UNITS(2.4ML), BERAHYALURONIDASE ALFA-PMPH · INJECTABLE · INJECTION

Approval history

2026-07-10Efficacy · Supplement 12 · priority — Letter ↗AP
2026-06-24Efficacy · Supplement 4 · standard — Letter ↗AP
2026-06-12Efficacy · Supplement 9 · priority — Letter ↗AP
2026-05-12Labeling · Supplement 7 · standard — Letter ↗AP
2026-04-24Efficacy · Supplement 3 · standard — Letter ↗AP
2026-04-06Labeling · Supplement 13 · standard — Letter ↗AP
2026-02-10Efficacy · Supplement 2 · priority — Label ↗AP
2025-11-21Efficacy · Supplement 1 · priority — Letter ↗AP
2025-09-19Type 1 - New Molecular Entity · Original · priority — Label ↗AP
2025-09-19Efficacy · Original · priority — Medication Guide ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →