- The US FDA has granted approval to Rozlytrek for ROS1-positive m-NSCLC in adults and accelerated approval for solid tumors having NTRK gene fusion in adults & pediatric patients aged≥ 12yrs.
- The approvals are based on integrated analysis of P-II STARTRK-2, P-I STARTRK-1, P-I ALKA-372-001 and P-I/II STARTRK-NG study resulted in 78% ORR, 1.8-36.8+ mos. DoR in ROS1-positive, m-NSCLC patients and 57% ORR and 2.8 to 26.0+ mos. DoR in patients with NTRK gene fusion-positive, LA/m-solid tumors
- Rozlytrek (PO) is a first selective tyrosine kinase inhibitor targeting TRK A/B/C and ROS1 proteins, blocking ROS1 and NTRK kinase activity thus resulting in the death of cancer cells with ROS1 or NTRK gene fusions
Click here to read full press release/ article | Ref: Roche | Image: SF Gate