Therapy Areas: Oncology
FDA approves oncology drug Rozlytrek that targets key genetic driver of cancer
16 August 2019 -

The US Food and Drug Administration (FDA) on Thursday granted accelerated approval for Rozlytrek (entrectinib) for the treatment of patients whose cancers have the specific genetic defect NTRK (neurotrophic tyrosine receptor kinase) gene fusion and for whom there are no effective treatments.

The approval was granted to Genentech Inc, part of the Roche Group (SWX:ROG).

Accelerated approval commits the sponsor to provide additional data to the FDA. Rozlytrek also received Priority Review, Breakthrough Therapy and Orphan Drug designation.

The ability of Rozlytrek to shrink tumors was evaluated in the company's four clinical trials studying 54 adults with NTRK fusion-positive tumors. Among the 31 patients with tumor shrinkage, 61% had tumor shrinkage persist for nine months or longer. The most common cancer locations were the lung, salivary gland, breast, thyroid and colon/rectum.

Additionally, Rozlytrek was approved for the treatment of adults with non-small cell lung cancer whose tumors are ROS1-positive (mutation of the ROS1 gene) and have spread to other parts of the body (metastatic). In clinical studies, among the 40 patients with tumor shrinkage, 55% had tumor shrinkage persist for 12 months or longer.



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