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Roche's Entrectinib Shrinks Tumors Harboring NTRK, ROS1 Or ALK Gene Fusions

Swiss drug major Roche (RHHBY) said that its investigational medicine Entrectinib shrank tumours in all 11 children and adolescents who had neurotrophic tyrosine receptor kinase, ROS1 or anaplastic lymphoma kinase fusion-positive solid tumours in a phase I/II study, dubbed STARTRK-NG. Complete responses were observed in 2 patients with tumours harbouring NTRK and ALK fusions.

In the study, of the 11 patients, five patients with primary high-grade tumours in the central nervous system or CNS had an objective response, including one patient with a complete response.

"We are encouraged by the results we have seen with Entrectinib in children with paediatric and adolescent cancers, including those with tumours in the brain," said Sandra Horning, Roche's Chief Medical Officer and Head of Global Product Development.

The safety profile of Entrectinib was consistent with that seen in previous analyses, the company said.

Entrectinib for both the treatment of paediatric and adult patients with NTRK fusion-positive, locally advanced or metastatic solid tumours who have either progressed following prior therapies or as an initial therapy when there are no acceptable standard therapies, and for the treatment of people with metastatic ROS1-positive NSCLC is under priority review by the FDA.

The FDA expects to make a decision on approval by August 18, 2019.

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