Roche Canada announced that Health Canada has granted market authorization to Rozlytrek (entrectinib) for the treatment of patients with ROS1-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC), not previously treated with crizotinib.
This new authorization is based on an integrated analysis from three single-arm, open-label clinical trials evaluating Rozlytrek in the treatment of ROS1-positive advanced NSCLC adult patients, not previously treated with crizotinib. The data show that the overall response rate was 73.4% (69/94) in patients who were treated with Rozlytrek. In patients with central nervous system (CNS) metastases at baseline who were treated with Rozlytrek, the intracranial response rate was 50% (17/34).
The most common adverse drug reactions (>10 % for all grades) with Rozlytrek seen in the clinical trials were fatigue (47.9%), constipation (45.9%), dysgeusia (43.7%), edema (39.7%), dizziness (38.3%), diarrhea (34.6%) and nausea (34.4%).