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ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS › ANTINEOPLASTIC AGENTS › MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES › PD-1/PD-L1 (Programmed cell death protein 1/death ligand 1) inhibitors
durvalumab
L01FF03
Forms & Strengths
- Intravenous solution: 50 mg/mL (120 mg/2.4 mL single-dose vial)
- Intravenous solution: 50 mg/mL (500 mg/10 mL single-dose vial)
Adult Dosing
- Non-Small Cell Lung Cancer (Stage III): 10 mg/kg IV every 2 weeks or 1500 mg every 4 weeks for up to 12 months
- Small Cell Lung Cancer (Extensive-stage): 1500 mg IV every 3 weeks with chemotherapy for 4 cycles, then 1500 mg IV every 4 weeks as maintenance
- Biliary Tract Cancer: 1500 mg IV every 3 weeks with gemcitabine and cisplatin for up to 8 cycles, then 1500 mg IV every 4 weeks
- Hepatocellular Carcinoma: 1500 mg IV every 4 weeks in combination with tremelimumab-actl as a single dose, then durvalumab monotherapy
Pediatric Dosing
- Safety and efficacy in pediatric patients have not been established
Indications
- Unresectable Stage III non-small cell lung cancer (NSCLC) without disease progression following platinum-based chemoradiation
- Extensive-stage small cell lung cancer (ES-SCLC) in combination with etoposide and carboplatin or cisplatin
- Locally advanced or metastatic biliary tract cancer (BTC) in combination with gemcitabine and cisplatin
- Unresectable hepatocellular carcinoma (HCC) in combination with tremelimumab
Mechanism of Action
- Human monoclonal antibody (IgG1 kappa) that blocks the interaction of programmed cell death ligand 1 (PD-L1) with PD-1 and CD80 (B7-1)
- Releases PD-L1/PD-1 pathway-mediated inhibition of the immune response, reactivating anti-tumor T-cell responses
Contraindications
- Severe hypersensitivity to durvalumab or any of its excipients
Adverse Reactions
- Immune-mediated pneumonitis
- Immune-mediated colitis
- Immune-mediated hepatitis
- Immune-mediated endocrinopathies (hypothyroidism, hyperthyroidism, adrenal insufficiency, type 1 diabetes mellitus)
- Immune-mediated nephritis with renal dysfunction
- Immune-mediated dermatologic adverse reactions (rash, severe cutaneous adverse reactions)
- Fatigue, musculoskeletal pain, cough, nausea, decreased appetite
Drug Interactions
- Systemic corticosteroids and immunosuppressants should be avoided before starting durvalumab due to potential interference with pharmacodynamic activity
- Corticosteroids and other immunosuppressive agents can be used to manage immune-mediated adverse reactions after initiation of treatment
Curated Content: Needs Vetting Before Put to Clinical Use