Rozlytrek

Disease:

ROS1-positive, metastatic non-small cell lung cancer (NSCLC), as well as treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.

About NSCLC:

NSCLC is any type of epithelial lung cancer other than small cell lung carcinoma (SCLC) and accounts for 84% of all lung cancers. The most common types of NSCLC are squamous cell carcinoma, large cell carcinoma and adenocarcinoma. While the ROS1 gene fusion can be found in any person with NSCLC, young never-smokers have the highest incidence of ROS1-positive NSCLC. NTRK gene fusions have been identified in a broad range of solid tumor types, with a higher incidence in certain tumor types including NSCLC.

About NTRK gene fusion-positive cancer:

NTRK gene fusion-positive cancer occurs when the NTRK1/2/3 genes fuse with other genes, resulting in altered TRK proteins (TRKA/TRKB/TRKC) that can activate signaling pathways involved in the proliferation of certain types of cancer. NTRK gene fusions are present in tumors irrespective of site of origin and have been identified in a broad range of solid tumor types.

What makes it unique:

Rozlytrek’s FDA approval for two rare types of cancer is a signfiicant advance for patients that combines a targeted medicine and genomic testing to bring a new treatment options to patients. It is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions. Biomarker testing for ROD1 in NSCLC and NTRK fusions is the only way to identify people who are eligible for treatment. It also marks Roche’s first FDA-approved tumor-agnostic medicine.

Companion Diagnostic:

Currently being submitted to the FDA.