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

By Vassia Barba contact

- 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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