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U. S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI . . . NEW YORK-- (BUSINESS WIRE)-- Nuvation Bio Inc (NYSE: NUVB), a global oncology company focused on tackling some of the toughest challenges in cancer treatment, today announced that the U S Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC
FDA Approves Talectrectinib (Ibtrozi) for ROS1-Positive Lung Cancer 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 cell lung cancer (NSCLC) How Was Taletrectinib Studied? Taletrectinib was evaluated in two international clinical trials (TRUST-I and TRUST-II), involving patients whose lung cancer tested positive for the
FDA Approves Taletrectinib for ROS1-Positive NSCLC Treatment 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, 2025, for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC)
Taletrectinib Increases Already Broad Selection of ROS1+ NSCLC . . . 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 this approval, CancerNetwork® spoke with Jorge Nieva, MD, an associate professor of clinical medicine at the Keck School of Medicine of the University of Southern California, about the evolving
Taletrectinib in ROS1+ Non–Small Cell Lung Cancer: TRUST Taletrectinib is an oral, potent, CNS-active, selective, next-generation ROS1 tyrosine kinase inhibitor (TKI) We report integrated efficacy and safety from registrational taletrectinib studies in ROS1 + non–small cell lung cancer
Taletrectinib Approved for ROS1-Positive Non–Small Cell Lung Cancer The FDA has granted approval to the kinase inhibitor taletrectinib (Ibtrozi™, Nuvation Bio Inc ) for the treatment of adults with locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC)
Taletrectinib Approved for ROS1-Positive NSCLC | AJMC Today’s approval of taletrectinib (Ibtrozi; Nuvation Bio Inc) by the FDA for ROS1-positive locally advanced or metastatic non–small cell lung cancer (NSCLC) comes on the heels of the January
NCCN Guidelines Now Recommend Taletrectinib for ROS1+ NSCLC The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Non-Small Cell Lung Cancers (NSCLC) have added taletrectinib (Ibtrozi) as a preferred agent for the