FDA Approves Imfinzi (durvalumab) for Resectable NSCLC and Other Indications

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FDA Published June 2, 2026 Medically reviewed June 2, 2026 DOI ↗ By Dr. Julia Lee, PhD · Oncology, Genomics & Drug Development

Key Takeaway

Consider Imfinzi for multiple cancers including resectable NSCLC, Stage III NSCLC, SCLC, BTC, HCC, dMMR endometrial cancer, MIBC, and GC/GEJC.

The FDA has approved Imfinzi (durvalumab), a PD-L1 blocking antibody, for several new indications across lung cancer, biliary tract cancer, hepatocellular carcinoma, endometrial cancer, bladder cancer, and gastric/gastroesophageal junction adenocarcinoma. For resectable non-small cell lung cancer (NSCLC), Imfinzi is approved in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent adjuvant therapy after surgery, for patients with tumors ≥4 cm and/or node-positive disease and no EGFR mutations or ALK rearrangements. Additionally, Imfinzi as a single agent is approved for unresectable Stage III NSCLC after concurrent chemoradiation, and in combination with tremelimumab-actl and chemotherapy for metastatic NSCLC. In small cell lung cancer, Imfinzi is approved for limited-stage disease after chemoradiation and for extensive-stage disease in combination with etoposide and platinum. Other approvals include combination regimens for biliary tract cancer, hepatocellular carcinoma, mismatch repair deficient endometrial cancer, muscle invasive bladder cancer, and resectable gastric/gastroesophageal junction adenocarcinoma. These approvals expand treatment options for patients with these malignancies.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Imfinzi is a programmed death-ligand 1 (PD-L1) blocking antibody. It binds to PD-L1 and blocks its interaction with PD-1 and CD80, thereby removing the inhibitory effects of PD-L1 on antitumor immune responses.

Indication & Patient Population

Imfinzi is indicated for: - In combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by single-agent adjuvant treatment after surgery, for resectable NSCLC (tumors ≥4 cm and/or node positive) without EGFR mutations or ALK rearrangements. - As a single agent for unresectable Stage III NSCLC after concurrent chemoradiation. - In combination with tremelimumab-actl and platinum-based chemotherapy for metastatic NSCLC without sensitizing EGFR mutations or ALK aberrations. - As a single agent for LS-SCLC after concurrent chemoradiation. - In combination with etoposide and carboplatin or cisplatin for first-line ES-SCLC. - In combination with gemcitabine and cisplatin for locally advanced or metastatic BTC. - In combination with tremelimumab-actl for uHCC. - In combination with carboplatin and paclitaxel followed by single-agent Imfinzi for primary advanced or recurrent dMMR endometrial cancer. - In combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single-agent adjuvant treatment after radical cystectomy for MIBC. - In combination with FLOT as neoadjuvant and adjuvant treatment, followed by single-agent Imfinzi for resectable GC/GEJC.

Dosing & Administration

Administer as an intravenous infusion over 60 minutes after dilution. For neoadjuvant and adjuvant treatment of resectable NSCLC: weight ≥30 kg: neoadjuvant Imfinzi 1,500 mg with chemotherapy every 3 weeks for up to 4 cycles; adjuvant Imfinzi 1,500 mg every 4 weeks for up to 12 cycles. Weight <30 kg: neoadjuvant 20 mg/kg every 3 weeks; adjuvant 20 mg/kg every 4 weeks. For unresectable Stage III NSCLC: weight ≥30 kg: 10 mg/kg every 2 weeks or 1,500 mg every 4 weeks. Dosing for other indications not fully detailed in label.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Imfinzi provides a PD-L1 inhibitor option across multiple tumor types, often in combination with chemotherapy or other agents. It is indicated for specific patient populations defined by tumor stage, biomarker status, and prior treatment.

Study Details

Study typeFda approval

PublishedMay 2017

View Original Abstract ↓

1 INDICATIONS AND USAGE IMFINZI is a programmed death-ligand 1 (PD-L1) blocking antibody indicated: • in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, for the treatment of adult patients 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. ( 1.1 ) • as a single agent, for the treatment of adult patients with unresectable, Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.1 ) • in combination with tremelimumab-actl and platinum-based chemotherapy, for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. ( 1.1 ) • as a single agent, for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. ( 1.2 ) • in combination with etoposide and either carboplatin or cisplatin, as first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). ( 1.2 ) • in combination with gemcitabine and cisplatin, as treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). ( 1.3 ) • in combination with tremelimumab-actl, for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). ( 1.4 ) • in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test. ( 1.5 , 2.1 ) • in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, for the treatment of adult patients with muscle invasive bladder cancer (MIBC). ( 1.6 ) • in combination with fluorouracil, leucovorin, oxaliplatin, and docetaxel (FLOT) chemotherapy as neoadjuvant and adjuvant treatment, followed by single agent IMFINZI, for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC). ( 1.7 ) 1.1 Non-Small Cell Lung Cancer • IMFINZI in combination with platinum-containing chemotherapy as neoadjuvant treatment, followed by IMFINZI continued as a single agent as adjuvant treatment after surgery, is indicated for the treatment of adult patients 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. • IMFINZI, as a single agent, is indicated for the treatment of adult patients with unresectable Stage III NSCLC whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT). • IMFINZI, in combination with tremelimumab-actl and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing EGFR mutations or ALK genomic tumor aberrations. 1.2 Small Cell Lung Cancer • IMFINZI, as a single agent, is indicated for the treatment of adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy (cCRT). • IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). 1.3 Biliary Tract Cancers IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). 1.4 Hepatocellular Carcinoma IMFINZI, in combination with tremelimumab-actl, is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). 1.5 Endometrial Cancer IMFINZI, in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent, is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR) as determined by an FDA-approved test [see Dosage and Administration (2.1)]. 1.6 Bladder Cancer IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by single agent IMFINZI as adjuvant treatment following radical cystectomy, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC). 1.7 Gastric or gastroesophageal junction adenocarcinoma IMFINZI in combination with fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) as neoadjuvant and adjuvant treatment, followed by single-agent IMFINZI, is indicated for the treatment of adult patients with resectable gastric or gastroesophageal junction adenocarcinoma (GC/GEJC).