Roche's NTRK tumour-agnostic therapy Rozlytrek approved in Europe

Roche Rituxan approval

Roche’s tumour-agnostic therapy Rozlytrek has been approved in the European Union for people with tumours with the NTRK mutation, meaning Bayer’s class rival faces competition in Europe for the first time.

Last September Bayer’s Vitrakvi became the first NTRK inhibitor class drug approved in Europe and the first ever drug licensed to tackle tumours solely based on their genetic signature, rather than their location in the body.

Following a positive opinion from the CHMP scientific committee in May, the European Commission granted a conditional marketing authorisation for Rozlytrek (entrectinib) for adults and children aged 12 years of age and older expressing a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

To be eligible patients must have a disease that is locally advanced, metastatic, or face severe consequences following surgery.

They must also have not previously received therapy from an NTRK inhibitor.

The European Commission has also approved Rozlytrek for the treatment of adults with ROS1-positive, advanced non-small cell lung cancer (NSCLC) not previously treated with ROS1 inhibitors.

Roche noted that approval is based on results from the integrated analysis of the pivotal phase 2 STARTRK-2, phase 1 STARTRK-1 and phase 1 ALKA-372-001 trials, and data from the phase 1/2 STARTRK-NG study.

However conditional approval means that the drug’s license is reviewed every year until confirmatory data from a larger trial.

Results so far showed Rozlytrek shrank tumours in more than half of people with NTRK fusion-positive, locally advanced or metastatic solid tumours, producing an overall response rate (ORR) of 63.5% in a group of 74 patients.

Objective responses were observed across 14 tumour types and median duration of response was 12.9 months.

In ROS1-positive, advanced NSCLC, Rozlytrek shrank tumours in 73.4% of people with the disease.

In a group of 161 patients with a minimum of six months follow up, including 29% of patients with central nervous system metastases at baseline, ORR was observed to be 67.1%.

Roche is developing a companion diagnostic in conjunction with Foundation Medicine to develop a companion diagnostic that will help identify people with NTRK and ROS1 gene fusions.

Rozlytrek was approved by the FDA in the NTRK indication in August last year, following on from a first approval in Japan in June last year.

Bayer’s Vitrakvi (larotrectinib) was approved in the US in for NTRK cancers in November 2018.