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  1. 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 ...

  2. 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 (NSCLC). …

  3. ROS1+ NSCLC Treatment | IBTROZI™ (taletrectinib)

    PLAY ON IBTROZI is a nonchemotherapy, targeted oral treatment designed specifically for adults with ROS1+ NSCLC What is IBTROZI? IBTROZI™ (taletrectinib) is a prescription medicine used to treat …

  4. 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, 2025, for …

  5. NCCN Guidelines Now Recommend Taletrectinib for ROS1+ NSCLC

    Jun 25, 2025 · 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 …

  6. Taletrectinib in ROS1+ Non–Small Cell Lung Cancer: TRUST

    Apr 3, 2025 · 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 …

  7. FDA Approves Taletrectinib in ROS1+ NSCLC - CancerNetwork

    Jun 11, 2025 · The FDA has approved taletrectinib (Ibtrozi) for patients with locally advanced or metastatic ROS1 -positive non–small cell lung cancer (NSCLC), according to a press release from …

  8. IBTROZI for the Treatment of Non-small Cell Lung Cancer, US

    Dec 9, 2025 · IBTROZI™ (taletrectinib) is a non-chemotherapy, targeted oral medicine available as 200mg capsules. Credit: Nuvation Bio, Inc. IBTROZI ™ (taletrectinib) is a tyrosine kinase inhibitor …

  9. Ibtrozi™ (Taletrectinib) | A New Era in ROS1-Positive NSCLC ...

    Jun 22, 2025 · Ibtrozi™ (taletrectinib) is a next-generation, oral ROS1 tyrosine kinase inhibitor (TKI), approved by the U.S. FDA on June 11, 2025. It’s designed to treat adult patients with locally …

  10. Taletrectinib Approved for ROS1-Positive NSCLC | AJMC

    Jun 11, 2025 · 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 …