FDA approves taletrectinib for ROS1-positive non-small cell ...
On June 11, 2025, the Food and Drug Administration approved taletrectinib (Ibtrozi, Nuvation Bio Inc.), a kinase inhibitor, for adults with locally advanced or metastatic ROS1-positive non-small ...
Description: The purpose of this document is to discuss the clinical considerations and general management of taletrectinib for the treatment of ROS1-positive non-small cell lung cancer …
Nuvation Bio Inc. - U.S. Food and Drug Administration ...
Jun 11, 2025 · NEW YORK-- (BUSINESS WIRE)-- Nuvation Bio Inc. (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, …
FDA Approves Taletrectinib for ROS1-Positive NSCLC Treatment
Jun 13, 2025 · FDA approval of Taletrectinib for ROS1 positive Non Small Cell Lung Cancer Taletrectinib was approved by the U.S. Food and Drug Administration (FDA) on June 11, …
Taletrectinib Recommended in NCCN Guidelines for ROS1 ...
Jul 31, 2025 · Taletrectinib (Ibtrozi; Nuvation Bio) was added to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Non-Small Cell Lung …
Taletrectinib Increases Already Broad Selection of ROS1 ...
On June 11, 2025, the FDA approved taletrectinib (Ibtrozi) for the treatment of patients with locally advanced or metastatic ROS1 -positive non–small cell lung cancer (NSCLC). 1 In the wake of …
FDA Approves Talectrectinib (Ibtrozi) for ROS1-Positive Lung ...
On June 11, 2025, the U.S. Food and Drug Administration (FDA) approved taletrectinib (Ibtrozi), a new targeted therapy for adults with locally advanced or metastatic ROS1-positive non-small …
FDA Approves Ibtrozi (taletrectinib) for Advanced ROS1 ...
Ibtrozi is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor therapy approved for the treatment of adult patients with advanced ROS1-positive non-small …
Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study ...
Sep 30, 2025 · Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI™ (taletrectinib) for the Adjuvant Treatment of ROS1-Positive Early-Stage Non-Small Cell Lung …
Ibtrozi Approved for Advanced ROS1-Positive NSCLC - Cancer ...
Jun 12, 2025 · The US Food and Drug Administration (FDA) has approved Ibtrozi (taletrectinib) for the treatment of adults with locally advanced or metastatic, ROS1 -positive non-small cell lung …