Unresectable Stage III NSCLC (after concurrent chemoradiation, PACIFIC setting); Extensive-stage small cell lung cancer (first-line, with etoposide and carboplatin/cisplatin); Biliary tract cancer (with gemcitabine and cisplatin, first-line); Hepatocellular carcinoma (with tremelimumab); Endometrial carcinoma
NSCLC (Stage III): 10 mg/kg IV q2w for up to 12 months
ES-SCLC: 1500 mg IV q3w × 4 cycles with chemo, then 1500 mg IV q4w maintenance
Biliary tract: 1500 mg IV q3w × 8 cycles with chemo, then 1500 mg IV q4w
Weight-based: For patients <30 kg, use weight-based dosing at 20 mg/kg
Injection: 50 mg/mL solution in 2.4 mL (120 mg) and 10 mL (500 mg) single-dose vials
Refer to the complete prescribing information for contraindications. Imfinzi prescribing should account for patient-specific factors including hypersensitivity to the active ingredient or any excipients.
Important warnings and precautions are detailed in the full prescribing information. Healthcare providers should review all boxed warnings, if applicable, and precautionary guidance before prescribing Imfinzi.
Fatigue (34%), nausea (22%), cough (21%), musculoskeletal pain (16%), rash (16%), pneumonitis (13%), decreased appetite (12%)
Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.
Consult the complete prescribing information for drug interactions, including effects on CYP enzymes, transporters, and concomitant medications that may require dose adjustments or monitoring.
Consult the full prescribing information for pregnancy-related considerations.
Refer to prescribing information for lactation guidance.
Pediatric safety and efficacy information is detailed in the full label.
Dose modifications for organ impairment are specified in the complete prescribing information.
Durvalumab is a human IgG1 kappa monoclonal antibody that binds to PD-L1 and blocks PD-L1 binding to PD-1 and CD80 (B7.1), countering PD-L1-mediated inhibition of immune responses and enhancing T-cell-mediated anti-tumor activity.
Half-life: approximately 18 days. Clearance: 8.2 mL/h. Vd: 5.6 L. Steady-state by ~16 weeks. Linear PK at doses ≥3 mg/kg q2w. Not significantly affected by age, weight, gender, or mild-moderate renal impairment.
Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.
Imfinzi has FDA-approved indications across the following cancer types covered on PipelineEvidence: