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A ROS1 and NTRK pill that also works after other ROS1 drugs fail, with dizziness as its signature side effect.
Repotrectinib is a compact macrocyclic ROS1 and TRK inhibitor whose small size lets it bind kinases carrying solvent-front mutations such as ROS1 G2032R, the usual escape route from crizotinib and entrectinib. It is used in ROS1-positive non-small-cell lung cancer both in patients who have never had a ROS1 drug and in those whose disease has progressed on one, and in NTRK-fusion solid tumours of any type. In TRIDENT-1 the response rate was 79% in TKI-naive and 38% in TKI-pretreated ROS1-positive NSCLC. It was approved in November 2023 for ROS1 and June 2024 for NTRK fusions (tumour-agnostic). Dizziness and other neurological effects from TRK inhibition are its signature toxicity, and zidesamtinib (2026) offers a TRK-sparing alternative with fewer neurologic effects. In short, it is the ROS1 pill that still works after other ROS1 drugs fail.
Compact macrocyclic ROS1/TRK inhibitor active against solvent-front mutations. Connects to ROS1 and NTRK.
1.Repotrectinib 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).
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: repotrectinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2022-06-03 | Turning Point Therapeutics to Bristol Myers Squibb Repotrectinib (Augtyro), ROS1 and NTRK inhibitor | Acquisition | not disclosed | $4.1bn | source |
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Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic where surgical resection is likely results in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 2.3 years later, when the FDA's table was read. source
| Region | Year | Indication |
|---|---|---|
| US | 2023 | ROS1+ locally advanced or metastatic NSCLC |
| US | 2024 | NTRK-fusion solid tumours (tumour-agnostic) |
| EU | 2025 | ROS1+ NSCLC; NTRK+ solid tumours; 13 Jan 2025 (conditional) · Conditional marketing authorisation |
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Query for this drug: (TITLE:"Repotrectinib" OR ABSTRACT:"Repotrectinib" OR TITLE:"Augtyro" OR ABSTRACT:"Augtyro") 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 Repotrectinib, not a curated reading list.
Shares PROFILE 1001 ROS1 expansion cohort, ROS1 fusion (ROS1-positive), Thyroid cancer (KEGG map), NTRK1/2/3 gene fusion.
Shares A Study of Repotrectinib (TPX-0005) in Patients With Advanced Solid Tumors Harboring ALK, ROS1, or NTRK1-3 Rearrangements, PROFILE 1001 ROS1 expansion cohort, NTRK fusion-positive non-small-cell lung cancer, ROS1-positive non-small-cell lung cancer.
Shares Thyroid cancer (KEGG map), NTRK1/2/3 gene fusion, Inflammatory myofibroblastic tumour (IMT), NTRK fusion-positive non-small-cell lung cancer.
Shares ROS1 fusion (ROS1-positive), ROS1, ROS1-positive non-small-cell lung cancer, Lung cancer (all types).
Shares A Study of Repotrectinib Versus Crizotinib in Participants With Locally Advanced or Metastatic Tyrosine Kinase Inhibitor (TKI)-naïve ROS1-positive Non-Small Cell Lung Cancer (NSCLC) (TRIDENT-3), PROFILE 1001 ROS1 expansion cohort, ROS1 fusion (ROS1-positive), Inflammatory myofibroblastic tumour (IMT).
Shares NTRK1/2/3 gene fusion, NTRK, KRAS wild-type pancreatic ductal adenocarcinoma, Pancreatic ductal adenocarcinoma.
Shares PROFILE 1001 ROS1 expansion cohort, ROS1 fusion (ROS1-positive), NTRK1/2/3 gene fusion, Inflammatory myofibroblastic tumour (IMT).
Shares ROS1 fusion (ROS1-positive), ROS1, Small-molecule kinase inhibitors, Non-small-cell lung cancer.