The U.S. Food and Drug Administration has approved the biologic license application (BLA) 761069 for IMFINZI, the brand name for the monoclonal antibody durvalumab. IMFINZI is administered intravenously and targets the programmed death‑ligand 1 (PD‑L1) pathway. The product is manufactured by AstraZeneca Pharmaceuticals LP.
The approval process included a priority review for efficacy. The first supplemental submission (submission 13) received approval on 19 Nov 2019. A subsequent priority supplemental submission (submission 23) was approved on 18 Nov 2020. Additional labeling supplements were filed in 2024 (submission 48) and are scheduled through 2026 (submission 60), reflecting ongoing updates to the product label.
IMFINZI is supplied as an injectable solution containing 50 mg/mL of durvalumab, packaged under NDC codes 0310‑4500‑12 and 0310‑4611‑50. It is classified as a human prescription drug.
The FDA’s openfda record lists the product under the pharmacologic class of PD‑L1 blockers and monoclonal antibodies, confirming its mechanism of action as a programmed death‑ligand 1 antagonist.
Regulatory UpdatesSep 18, 2026•3 min read
FDA Grants Priority Approval for AstraZeneca's IMFINZI (Durvalumab) BLA761069
The FDA approved AstraZeneca’s IMFINZI (durvalumab) under BLA761069, with priority review for efficacy and ongoing labeling updates through 2026.
Compiled by the Pharmacountry team · Source: FDA.gov
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