The FDA approved Genentech’s Rozlytrek (entrectinib) for adults and adolescents who have cancers with a common biomarker — only the third time the agency has approved a cancer treatment on the basis of a biomarker rather than for treatment of a specific tumor.
The agency handed the Roche subsidiary accelerated approval for the drug for treating adults and adolescents whose cancers have the genetic defect neurotropic tyrosine receptor kinase (NTRK) gene fusion and who have no other treatment options.
The approval includes an indication for pediatric patients aged 12 and older with NTRK-fusion-positive tumors. It was supported by efficacy information gathered mainly from adults.
Rozlytrek also received approval for treating adults with non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive and have spread to other areas of the body.