Edition:
India

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


Friday, 16 Aug 2019 

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.