Trials & Filings

Roche Wins Two Approvals for Cancer Drug Rozlytrek

Becomes third tumor-agnostic drug to win FDA Approval

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By: Kristin Brooks

Managing Editor, Contract Pharma

The U.S. FDA granted accelerated approval of Roche’s Rozlytrek (entrectinib), a treatment for patients whose cancers have the specific genetic defect, NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments. This is the third time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated, marking a new paradigm in the development o...

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