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

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

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  • 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

Ref: Roche | Image: Roche

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