2 Information about entrectinib

Marketing authorisation indication

2.1 Entrectinib (Rozlytrek, Roche) is indicated as monotherapy 'for the treatment of adult patients with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors'.

2.2 On 28 May 2020 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product entrectinib intended for the treatment of ROS1-positive advanced NSCLC.

Dosage in the marketing authorisation

2.3 The dosage schedule is available in the summary of product characteristics.


2.4 The list price for entrectinib is £5,160 for a 90‑capsule pack of 200-mg capsules, and £860 for a 30‑capsule pack of 100-mg capsules (excluding VAT, company submission). The company has a commercial arrangement. This makes entrectinib 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)