August 16, 2019 / 5:38 AM / 4 months ago

BRIEF-Roche Wins U.S. FDA Approval For Rozlytrek Cancer Treatment

Aug 16 (Reuters) - Roche Holding AG:

* FDA APPROVES ROCHE’S ROZLYTREKTM (ENTRECTINIB) FOR PEOPLE WITH ROS1-POSITIVE, METASTATIC NON-SMALL CELL LUNG CANCER AND NTRK GENE FUSION-POSITIVE SOLID TUMOURS

* FIRST FDA-APPROVED TREATMENT DESIGNED TO TARGET BOTH ROS1 AND NTRK THAT ALSO SHOWS RESPONSE IN CANCER THAT HAS SPREAD TO BRAIN

* ROCHE’S FIRST FDA-APPROVED TUMOUR-AGNOSTIC MEDICINE

* FDA HAS ALSO GRANTED ACCELERATED APPROVAL TO ROZLYTREK FOR TREATMENT OF 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

* APPROVALS ARE BASED ON RESULTS FROM INTEGRATED ANALYSIS OF PIVOTAL PHASE II STARTRK-2, PHASE I STARTRK-1 AND PHASE I ALKA-372-001 TRIALS, AND DATA FROM PHASE I/II STARTRK-NG STUDY Source text for Eikon: [tinyurl.com/y57hkeh9] Further company coverage: (Berlin Speed Desk)

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