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NICE Approves Entrectinib for ROS1-Positive NSCLC

The National Institute for Health and Care Excellence (NICE) is approving entrectinib (Rozlytrek, Roche) as a treatment option for ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors. 

The rare ROS1 mutation is found in fewer than 2% of NSCLC cases.

Entrectinib is a selective tyrosine kinase inhibitor designed to inhibit the kinase activity of the tropomyosin receptor kinase (TRK) A/B/C and ROS1 proteins.

NICE issued final draft guidance based on data from three clinical trials showing the daily oral treatment is effective at shrinking tumours, and slowing overall disease progression of the disease (16.8 months median progression-free).

The European Medicines Agency granted conditional marketing authorisation for entrectinib on 28th May. The US FDA approved the drug in August 2019.

The price is £5,160 for a 90-pack of 200 mg capsules, and £860 for a 30-pack of 100 mg capsules, but that is before the confidential discount for NHS patients.

Four hundred and twelve people in England are expected to be candidates for the treatment.

NICE guidance for England is usually followed by the NHS in Wales. The Scottish Medicines Consortium has paused drug assessments due to COVID-19.