2 Information about crizotinib

2 Information about crizotinib

Marketing authorisation

Crizotinib (Xalkori, Pfizer) as monotherapy is indicated 'for the treatment of adults with ROS1‑positive advanced non-small-cell lung cancer (NSCLC)'.

Dosage in the marketing authorisation

250 mg twice daily (500 mg daily) taken orally.

Dosing interruption and/or dose reduction may be needed based on individual safety and tolerability. If necessary, dose may be reduced to 200 mg twice daily and then 250 mg once daily.

An accurate and validated assessment for ROS1 should be done by laboratories with demonstrated proficiency in the specific test being used before starting crizotinib therapy. It is important that a well-validated and robust methodology is chosen to avoid false-negative or false-positive results.

For further details see the summary of product characteristics.

The summary of product characteristic states that there is limited information available in patients with ROS1‑positive NSCLC with non-adenocarcinoma histology, including squamous cell carcinoma.

Price

The list price of crizotinib is £4,689 for 60 capsules (excluding VAT; British national formulary [BNF] online, accessed December 2017).

The company has a commercial arrangement. This makes crizotinib 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)