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Ref Type
PMID
Authors
Title Ibtrozi (taletrectinib) FDA Drug Label
Journal Vol Issue Date Pages Journal Short Title
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219713
Abstract Text

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Taletrectinib Taletrectinib 9 4
Drug Name Trade Name Synonyms Drug Classes Drug Description
Taletrectinib Ibtrozi DS6051b|DS-6051B|DS-6051|AB-106 ROS1 Inhibitor 23 Trk Receptor Inhibitor (Pan) 33 Ibtrozi (taletrectinib) is an inhibitor of NTRK1/2/3 and ROS1 fusion proteins, which blocks downstream signaling and may lead to inhibition of tumor cell growth (PMID: 32591465). Ibtrozi (taletrectinib) is FDA-approved for use in patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ROS1 rearrange lung non-small cell carcinoma sensitive Taletrectinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (TRUST-II) that supported FDA approval, Ibtrozi (taletrectinib) treatment demonstrated safety in non-small cell lung cancer patients with ROS1 rearrangement and resulted in a confirmed investigator-assessed objective response rate (cORRinv) of 94% (17/18) and a disease control rate (DCR) of 100% in the treatment-naive cohort and a cORRinv of 55% (12/22) and DCR of 91% in the previously treated cohort (Ann Oncol (2023) 34 (suppl_2):S788-S789; NCT04919811). detail... detail...
ROS1 rearrange lung non-small cell carcinoma sensitive Taletrectinib FDA approved - On Companion Diagnostic Actionable In a Phase II trial (TRUST-I) that supported FDA approval, Ibtrozi (taletrectinib) therapy resulted in a 90.6% (96/106) overall response rate (ORR) and 95.3% disease control rate (DCR) in TKI-naive non-small cell lung cancer patients with ROS1 rearrangement and 51.5% (34/66) ORR and 83.3% DCR in pretreated patients, intracranial ORR of 87.5% (7/8) and DCR of 100% in patients with baseline brain lesions, and partial responses in 8 of 12 patients with secondary ROS1 G2032R (PMID: 38822758; NCT04395677). detail... 38822758