The US Food and Drug Administration approved Roche Holding AG’s personalized cancer treatment, which targets tumors with specific genetic mutations, irrespective of where in the body the disease started. The treatment, Rozlytrek, is a tyrosine kinase inhibitor that targets patients who must be identified via genetic profiling. It is approved to treat certain types of solid tumors, which show rare genetic anomalies called NTRK fusions. Individually, the mutations are rare and it is difficult to run dedicated tests for each. They have been identified in a broad range of solid tumor types, including breast, colorectal, pancreatic, and non-small cell lung cancers.
Since these NTRK fusions occur in a multitude of tumors, the company sees potentially broad application for Rozlytrek, in conjunction with diagnostic tests from its Foundation Medicine unit. Rozlytrek, already approved in Japan, is now available in the United States for adults and children 12 years of age and older. The FDA also approved it to treat adult patients with non-small-cell lung cancer, whose tumors show a genetic mutation called ROS1 fusion.
Rival treatment Vitrakvi from German drug maker Bayer has already won US backing for solid tumors that test positive for NTRK genes.