Rozlytrek (entrectinib), a small-molecule tyrosine receptor kinase (TRK) inhibitor, was approved by the US Food and Drug Administration (FDA) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer.
Separately, the product was granted accelerated approval for the treatment of adults or children over 12 years old with solid tumours that have a gene fusion of the neurotrophic tyrosine receptor kinase (NTRK).
Roche acquired the drug after its $1.7bn (€1.53bn) acquisition of Ignyta and received a priority review for the treatment from the FDA in February, only days after Bayer obtained exclusive rights on Loxo Oncology’s Vitrakvi (larotrectinib), its TRK inhibitor.
Following Rozlytrek’s approval, a spokesperson for Roche told us that the drug will be priced at $17,050 per month, significantly lower than Bayer’s for Viktrakvi, the cost for a monthly supply of which is $32,800.
In Phase I and II clinical trials, the treatment with Rozlytrek resulted to shrinking of tumours for 78% of ROS1-positive patients, and for nearly half of NTRK gene fusion-positive patients.
Roche has also received approval for Rozlytrek by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of adult and paediatric patients with NTRK fusion-positive, advanced recurrent solid tumours, as the first approved tumour-agnostic treatment in the country.
The product has also been granted priority medicines (PRIME) designation by the European Medicines Agency (EMA).