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  1. 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 ...

  2. Ibtrozi for Non-Small-Cell Lung Cancer - WebMD

    Jul 30, 2025 · Ibtrozi is a medicine called a kinase inhibitor that is used to treat a certain type of lung cancer called non-small-cell lung cancer (NSCLC) that is caused by an abnormal ROS1 …

  3. Lung Cancer Novel Agents in Metastatic NSCLC

    Dec 13, 2025 · Lung cancer affects more than 200,000 people in the United States annually; non–small cell lung cancer (NSCLC) accounts for approximately 85% of all lung cancer cases. …

  4. U.S. Food and Drug Administration Approves Nuvation Bio’s IBTROZI

    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, …

  5. 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 …

  6. Ibtrozi Approved for Advanced - Cancer Therapy Advisor

    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 …

  7. 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 …

  8. FDA Approves Nuvation Bio’s IBTROZI™ for Advanced ROS1-Positive Lung Cancer

    Jun 11, 2025 · IBTROZI is a highly selective ROS1 tyrosine kinase inhibitor (TKI) designed to address key challenges in treating ROS1-positive NSCLC, a rare and aggressive cancer type …

  9. FDA Approves Ibtrozi For Adults With ROS1+ NSCLC

    Jun 12, 2025 · Ibtrozi had a 90% response rate in treatment naïve adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer, according to the results of a news release.

  10. With lung cancer FDA nod, it's David versus Goliath

    Jun 11, 2025 · Nuvation Bio has won FDA approval for Ibtrozi, or taletrectinib, to challenge existing meds from Pfizer, BMS and Roche in ROS1-positive lung cancer.