Durvalumab, sold under the brand name Imfinzi, is an anti-cancer medication used for treatment of various types of cancer. It was developed by Medimmune/AstraZeneca. It is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to programmed cell death ligand 1 (PD-L1) on cancer cells and blocks interactions with PD-1 and CD80 (B7.1) on T cells.

Durvalumab is an immune checkpoint inhibitor drug. It was approved in for medical use in the United States in May 2017, and in the European Union in September 2018.

The US Food and Drug Administration (FDA) approved durvalumab for certain types of bladder, lung, and biliary tract cancer:

In June 2024, the US FDA approved durvalumab with carboplatin plus paclitaxel, followed by single-agent durvalumab, for adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient.

In August 2024, the FDA approved durvalumab with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent durvalumab as adjuvant treatment after surgery for adults with resectable (tumors ≥ 4 cm and/or node positive) non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) rearrangements. Efficacy was evaluated in AEGEAN (NCT03800134), a randomized, double-blind, placebo-controlled multicenter trial in 802 participants with previously untreated and resectable squamous or non-squamous NSCLC (stage IIA to select stage IIIB [AJCC, 8th edition]). Participants were randomized (1:1) to either durvalumab or placebo, with platinum-based chemotherapy, every 3 weeks for up to 4 cycles (neoadjuvant treatment) followed by either continued single-agent durvalumab or placebo, every 4 weeks for up to 12 cycles (adjuvant treatment).

In December 2024, the FDA expanded the indication of durvalumab to include adults with limited-stage small cell lung cancer whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. The efficacy was evaluated in ADRIATIC (NCT03703297), a randomized, double-blind, placebo-controlled trial in 730 participants with LS-SCLC whose disease had not progressed following concurrent platinum-based chemotherapy and radiation therapy. Participants were randomized 1:1:1 to receive durvalumab as a single agent, durvalumab in combination with tremelimumab, or placebo.

In March 2025, the FDA approved durvalumab with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent durvalumab as adjuvant treatment following radical cystectomy, for adults with muscle invasive bladder cancer. The efficacy was evaluated in NIAGARA (NCT03732677), a randomized, open-label, multicenter, phase III trial enrolling 1,063 participants who were candidates for radical cystectomy and had not received prior systemic therapy for bladder cancer. Participants were randomized (1:1) to receive neoadjuvant durvalumab with chemotherapy followed by adjuvant durvalumab after surgery or neoadjuvant chemotherapy followed by surgery alone.

In November 2025, the US FDA approved durvalumab with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT chemotherapy) as neoadjuvant and adjuvant treatment, followed by single agent durvalumab, for adults with resectable gastric or gastroesophageal junction adenocarcinoma.