Drug reference
Durvalumab is a human monoclonal antibody that selectively binds to programmed cell death ligand-1 (PD-L1), blocking its interaction with the programmed death-1 (PD-1) receptor and with CD80, and thereby potentiating an immune response to tumour cells.
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Non-small cell lung cancer (initiated by a specialist) ▶BY INTRAVENOUS INFUSION ▶Adult: 10 mg/kg every 2 weeks, consult product literature for information on dose adjustments based on individual patient safety and tolerability
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NICE decisions ▶Durvalumab for treating locally advanced unresectable non- small-cell lung cancer after platinum-based chemoradiation (May 2019) NICE TA578 Durvalumab (Imfinzi ®) monotherapy is recommended for use within the Cancer Drugs Fund as an option for treating locally advanced unresectable non-small cell lung cancer in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed after platinum-based chemoradiation only if: . they have had concurrent platinum-based chemoradiation, and . the conditions in the managed access agreement are followed. Patients whose treatment was started within the NHS before this guidance was published should have the option to continue treatment, without change to their funding arrangements, until they and their NHS clinician consider it appropriate to stop. www.nice.org.uk/guidance/ta578 Scottish Medicines Consortium (SMC) decisions SMC No. SMC2156 The Scottish Medicines Consortium has advised (June 2019) that durvalumab (Imfinzi ®) is accepted for use within NHS Scotland as monotherapy for the treatment of locally advanced, unresectable non-small cell lung cancer in adults whose tumours express PD-L1 on 1% of tumour cells and whose disease has not progressed following platinum-based chemoradiation therapy. This advice is contingent upon the continuing availability of the patient access scheme in NHS Scotland or a list price that is equivalent or lower.
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→Appendix 1: monoclonal antibodies
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▶Common or very common Cough. diarrhoea. dysphonia. dysuria. fever. flank pain. gastrointestinal discomfort. gastrointestinal disorders. hyperthyroidism. hypothyroidism. increased risk of infection. infusion related reaction. myalgia. night sweats. peripheral oedema. respiratory disorders. skin reactions. thyroiditis ▶Uncommon Adrenal insufficiency. glomerulonephritis. hepatic disorders. myopathy. nephritis. type 1 diabetes mellitus ▶Rare or very rare Diabetes insipidus. hypophysitis. hypopituitarism. myocarditis SIDE-EFFECTS, FURTHER INFORMATION Immune-related reactions Manufacturer advises that most immune- related adverse reactions resolved with appropriate management, including initiation of immunosuppressive treatment and treatment modifications—consult product literature. Infusion-related reactions Manufacturer advises to permanently discontinue treatment in patients with severe infusion reactions.
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Manufacturer advises effective contraception in women of childbearing potential during treatment and for at least 3 months after stopping treatment. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available. See also Pregnancy and reproductive function in Cytotoxic drugs p. 938.
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Manufacturer advises avoid—no information available.
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Manufacturer advises monitor for signs and symptoms of infusion- and immune- related reactions—consult product literature.
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Manufacturer advises for intravenous infusion, dilute to a concentration between 1 mg/mL and 15 mg/mL with Glucose 5% or Sodium Chloride 0.9%; give over 60 minutes through a low-protein binding in-line filter (pore size 0.2 or 0.22 micron). l HANDLING AND STORAGE Manufacturer advises store in a refrigerator (2–8°C) and protect from light—consult Immune system and malignant disease product literature for storage conditions after preparation of the infusion.
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There can be variation in the licensing of different medicines containing the same drug. Solution for infusion EXCIPIENTS: May contain Polysorbates ▶Imfinzi (AstraZeneca UK Ltd) A Durvalumab 50 mg per 1 ml Imfinzi 120mg/2.4ml concentrate for solution for infusion vials | 1 vial P £592.00 Imfinzi 500mg/10ml concentrate for solution for infusion vials | 1 vial P £2,466.00
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10 mg/kg every 2 weeks, consult product
First-line fragment. Read the complete Indications and Dose section above.
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