Roche’s Rozlytrek (entrectinib) Receives the US FDA Approval for ROS1-Positive Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

Roche’s Rozlytrek (entrectinib) Receives the US FDA Approval for ROS1-Positive Metastatic Non-Small Cell Lung Cancer and NTRK Gene Fusion-Positive Solid Tumors

Shots:

  • 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