FDA approves taletrectinib for ROS1-positive non-small cell lung cancer
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 ...
U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI …
Jun 11, 2025 · 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 …
FDA Approves Nuvation Bio’s Ibtrozi for Locally Advanced or …
Jun 12, 2025 · FDA Approves Ibtrozi for ROS1+ NSCLC: Ibtrozi (taletrectinib) has been approved for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer …
FDA Approves Ibtrozi for ROS1-Positive Lung Cancer
Jun 12, 2025 · On June 11, the Food and Drug Administration approved Ibtrozi (taletrectinib) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC). …
Nuvation Bio Enrolls First Patient in TRUST-IV Phase 3 Study of IBTROZI …
Sep 30, 2025 · Each year, more than one million people globally are diagnosed with non-small cell lung cancer (NSCLC), the most common form of lung cancer. It is estimated that approximately …
FDA Approves Ibtrozi for ROS1+ Advanced Non-Small Cell Lung Cancer
Jun 11, 2025 · For patients with ROS1-positive non-small cell lung cancer who had not previously received a tyrosine kinase inhibitor, Ibtrozi was associated with a high rate of disease …
Taletrectinib Approved for ROS1-Positive Non–Small Cell Lung Cancer
Jun 13, 2025 · 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 …
FDA clears Nuvation lung cancer drug, setting up battle with …
Jun 11, 2025 · The Food and Drug Administration has approved a new oral medication for an uncommon kind of tumor, clearing Nuvation Bio’s Ibtrozi on Wednesday for certain people …
FDA Approves Nuvation Bio’s IBTROZI™ for Advanced ROS1-Positive Lung Cancer
Jun 11, 2025 · New York, NY — The U.S. Food and Drug Administration (FDA) has approved IBTROZI™ (taletrectinib), a next-generation oral treatment developed by Nuvation Bio, for …
With lung cancer FDA nod, it's David versus Goliath
Jun 11, 2025 · Hung’s Nuvation Bio has won FDA approval for Ibtrozi, or taletrectinib, to treat patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).
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