Roche’s tumour-agnostic drug approved by FDA, priced under competitor drug

By Vassia Barba

- Last updated on GMT

(Image: Getty/andrei_r)
(Image: Getty/andrei_r)

Related tags Roche Food and drug administration FDA approval Cancer Bayer

Roche receives US FDA approval with two indications for Rozlytrek, prices the drug at almost half of Bayer’s similar drug.

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).

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