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A ROS1 lung-cancer pill approved in 2025 that works in the brain and after crizotinib, with fewer dizziness-type side effects than repotrectinib.
Taletrectinib is a selective, CNS-penetrant ROS1 tyrosine kinase inhibitor active against G2032R and other solvent-front mutations that cause resistance to crizotinib. It has limited TRK inhibition, which means fewer of the dizziness and neurological effects seen with repotrectinib. In the TRUST-I (China) and TRUST-II (global) studies, response rates were about 85 to 90% in TKI-naive patients and 50 to 60% after crizotinib, with intracranial responses and activity against G2032R. China approved it in January 2025 and the FDA in June 2025 for locally advanced or metastatic ROS1-positive NSCLC, developed by Nuvation Bio; hepatotoxicity and gastrointestinal effects are the main toxicities. Sequencing against crizotinib, entrectinib and repotrectinib is not settled. In short, taletrectinib is a ROS1 pill that works in the brain and after resistance, with fewer neurological side effects.
Selective ROS1 inhibitor active against G2032R and other solvent-front mutations with limited TRK inhibition (fewer neurologic effects). Connects to ROS1.
1.Taletrectinib slips into a pocket on ROS1.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA-approved June 2025.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE search: taletrectinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Region | Year | Indication |
|---|---|---|
| CN | 2025 | ROS1-positive NSCLC |
| US | 2025 | Locally advanced or metastatic ROS1-positive NSCLC |
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Query for this drug: (TITLE:"Taletrectinib" OR ABSTRACT:"Taletrectinib" OR TITLE:"Ibtrozi" OR ABSTRACT:"Ibtrozi") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Taletrectinib, not a curated reading list.
Shares ROS1 fusion (ROS1-positive), ROS1, Gene fusion, Small-molecule kinase inhibitors.
Shares ROS1, ROS1-positive non-small-cell lung cancer, Gene fusion, Lung cancer (all types).
Shares ROS1, ROS1-positive non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares Nuvation Bio, ROS1-positive non-small-cell lung cancer, Non-small-cell lung cancer.
Shares ROS1 fusion (ROS1-positive), ROS1, ROS1-positive non-small-cell lung cancer, Lung cancer (all types).
Shares ROS1, ROS1-positive non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares ROS1-positive non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.
Shares ROS1-positive non-small-cell lung cancer, Small-molecule kinase inhibitors, Non-small-cell lung cancer.