logo
Plus   Neg
Share
Email

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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
International Business Machines Corp. and Cúram Software, acquired by the tech giant in 2011, have agreed to pay $14.8 million to settle alleged violations of the False Claims Act, the Justice Department said in a statement. According to the DOJ, IBM and Cúram allegedly made material misrepresentations to the State of Maryland during a contract award process in 2011 and 2012. Lyrics website Genius Media Group Inc. has accused Google of copying some song lyrics directly from its website without permission, for the tech giant's search results. Genius told the Wall Street Journal that it is seeing falling traffic for the past several years as Google has been publishing lyrics in search pages on its own platform, with some of them lifted directly from the Genius website. CVS is planning to invest $10 million to create awareness among youth against the ill effects of e-cigarette. Over a period of next five year, the foundation would invest $50 million, aiming to achieve "nation's first tobacco-free generation." The "Be The First" campaign will also partner with American...
Follow RTT