Roche’s Rozlytrek (entrectinib) Receives MHLW’s Approval for NTRK Fusion-Positive Advanced Recurrent Solid Tumors in Adult and Pediatric Patients in Japan

Roche’s Rozlytrek (entrectinib) Receives MHLW’s Approval for NTRK Fusion-Positive Advanced Recurrent Solid Tumors in Adult and Pediatric Patients in Japan

Shots:

  • The approval is based on P-II STARTRK-2, P-I STARTRK-1, P-I ALKA-372-001 & P-I/II STARTRK-NG studies results assessing Rozlytrek in adults & pediatric patients with NTRK fusion-positive solid tumors, across 10 different tumor types, including CNS metastases solid tumors across 15 countries in 150+ clinical studies respectively  
  • The P-II STARTRK-2 study demonstrated that Rozlytrek shrank tumors in 50%+ patients, ORR (56.9%), mDOR (10.4 mos.), intracranial response (IC ORR) (50%). P-I/II STARTRK-NG resulted in shrinking tumors in children and adolescent
  • Rozlytrek (RXDX-101) is a personalized oral therapy indicated for NTRK 1/2/3 LA/m-solid tumors, inhibits the kinase activity of TRK A/B/C and ROS1 protein with its expected MHLW’s approval for ROS1 fusion-positive NSCLC in Japan

Click here to read full press release/ article | Ref: Roche | Image: Chem Indigest