Therapy Areas: Oncology
US FDA grants approval to Roche's Rozlytrek
19 August 2019 -

The US Food and Drug Administration (FDA) has granted approval to Switzerland-based Roche for its Rozlytrek (entrectinib) intended for the treatment of adults with ROS1-positive and metastatic non-small cell lung cancer (NSCLC), it was reported on Friday.

The firm has also received accelerated approval for the product to treat adult and paediatric patients 12 years of age and older with solid tumours, which have a neurotrophic tyrosine receptor kinase gene fusion without a known acquired resistance mutation.

Rozlytrek is an oral medicine and selective tyrosine kinase inhibitor developed to inhibit the kinase activity of the TRK A/B/C and ROS1 proteins. It holds capacity to inhibit ROS1 and NTRK kinase activity and is likely to result in the death of cancer cells with ROS1 or NTRK gene fusions. The product has received approvals based on data from the integrated analysis of the pivotal phase II STARTRK-2, phase I STARTRK-1 and phase I ALKA-372-001 trials, and data from the phase I/II STARTRK-NG study.

Roche has claimed that Rozlytrek shrank tumours in 78 percent of people with the disease and the duration of response (DoR) ranged from 1.8 to 36.8+ months in ROS1-positive and metastatic NSCLC.

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