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Osimertinib for untreated EGFR mutation-positive non-small-cell lung cancer

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2 Information about osimertinib

Marketing authorisation indication

Osimertinib (Tagrisso, AstraZeneca) is indicated 'for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) mutations'.

Dosage in the marketing authorisation

80 mg taken orally once daily until disease progression or unacceptable toxicity.

EGFR mutation status in tumour or plasma specimens should be determined using a validated test method.

Dosing interruption with or without dose reduction may be needed based on individual safety and tolerability. If dose reduction is necessary, then the dose should be reduced to 40 mg once daily.

Price

£5,770 for 80 mg and 40 mg osimertinib (pack of 30 tablets, excluding VAT; British national formulary online, accessed March 2019).

The company has a commercial arrangement (managed access agreement including a commercial access agreement). This makes osimertinib 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.