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Roche’s cancer drug Rozlytrek scores double approval from FDA

Published on 16/08/19 at 11:12am

The FDA has approved Roche’s Rozlytrek (entrectinib) as a treatment for adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC).

The US regulator also approved the drug as a treatment adult and paediatric patients 12 years of age and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy.  

In ROS1-positive NSCLC Rozlytrek shrunk tumours in 78% of patients while the drug shrank tumours in 57% of patients with tumours with an NTRK gene fusion.

Dr Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, commented: “Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting.

"Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.”

Louis Goss

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