2 Information about durvalumab

2 Information about durvalumab

Marketing authorisation indication

Durvalumab (Imfinzi, AstraZeneca) is indicated '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'.

Dosage in the marketing authorisation

10 mg/kg administered as an intravenous infusion over 60 minutes every 2 weeks, until disease progression or unacceptable toxicity or a maximum of 12 months.

Continue treatment for patients who are clinically stable with initial evidence of disease progression until disease progression is confirmed.

Dose escalation or reduction is not recommended. Dose withholding or discontinuation may be needed based on individual safety and tolerability.

In the PACIFIC trial a small number of patients had retreatment with durvalumab if their disease progressed after 12 months of therapy. However, durvalumab does not have a marketing authorisation for treating progressed disease. Therefore its use for retreatment is off-label and is not covered by this guidance.

Price

£592.00 per 120 mg/2.4 ml vial, £2,466.00 per 500 mg/10 ml vial (British national formulary online, accessed February 2019).

The company has a commercial arrangement. This makes durvalumab available to the NHS with a discount. The size of the discount is commercial in confidence. It is the company's responsibility to let relevant NHS organisations know details of the discount.

  • National Institute for Health and Care Excellence (NICE)