Augtyro (repotrectinib)
An approved treatment for NTRK Fusion Cancer.
The same compound appears under different names depending on the context. Here is how to identify Repotrectinib wherever you encounter it, plus the key facts at a glance.
- Generic name
- Repotrectinib
- Brand name
- Augtyro
- Development code
- TPX-0005
- Drug class
- TRK and ROS1 inhibitor (next generation)
- Manufacturer
- Bristol Myers Squibb
- How it's taken
- Taken by mouth: 160 mg once a day for the first 14 days, then 160 mg twice a day, with or without food, until the cancer grows or side effects become unacceptable.
An oral next-generation TRK inhibitor approved on June 13, 2024 under accelerated approval for adults and children 12 and older with NTRK fusion solid tumors, including tumors that have become resistant to Vitrakvi or Rozlytrek. It is the first US-approved drug that works after a prior TRK inhibitor fails.
Where Repotrectinib fits
The third FDA-approved TRK inhibitor and the one used after Vitrakvi or Rozlytrek stops working, because it still binds TRK proteins carrying solvent-front resistance mutations. It can also be used first, with a 58% response rate in untreated patients, but its nervous system side effects are more frequent than with the first-generation drugs, and it has no formulation for young children.
How Repotrectinib works
When a tumor stops responding to a first-generation TRK inhibitor, the usual cause is a new mutation at the entrance of the TRK protein's binding pocket, called a solvent-front mutation, that physically blocks the larger first-generation drugs. Repotrectinib is a smaller, rigid, ring-shaped molecule that still fits past those mutations and shuts the TRK signal off. It also blocks ROS1, which is why it was approved first for ROS1-positive lung cancer, and it crosses into the brain.
Mechanism: Next-generation TRK and ROS1 inhibitor with a compact structure that still binds when solvent-front resistance mutations are present
Side effects and safety
- Nervous system effects. Dizziness (65%), ataxia (28%) and cognitive changes (25%) at any grade; the dose is paused or lowered for severe effects.
- Lung inflammation. Interstitial lung disease or pneumonitis; report new cough or shortness of breath.
- Liver injury. Liver tests every 2 weeks for the first month, then monthly.
- Muscle pain with CPK rise. Myalgia with raised creatine phosphokinase; CPK is checked during treatment.
- High uric acid and bone fractures. Uric acid is monitored; fractures occurred and new bone pain should be reported.
- Harm to a fetus. Can harm an unborn baby and makes hormonal contraception less effective, so a non-hormonal method is needed during treatment and for 2 months after.
- Liver tests every 2 weeks for 1 month, then monthly
- CPK and uric acid during treatment
- Lung symptoms at each visit
The most common side effects in the label (426 patients in TRIDENT-1) were dizziness (65%), altered taste (54%), peripheral neuropathy such as numbness or tingling (49%), constipation (38%), shortness of breath (30%), ataxia, fatigue, cognitive changes and muscle weakness. Nervous system effects of some kind occurred in 77% of patients. The label warns about lung inflammation (interstitial lung disease), liver injury, muscle pain with raised CPK, high uric acid, bone fractures and harm to a fetus. There is no boxed warning.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Repotrectinib
Taken by mouth: 160 mg once a day for the first 14 days, then 160 mg twice a day, with or without food, until the cancer grows or side effects become unacceptable. It comes as 40 mg and 160 mg capsules only; there is no liquid or pediatric formulation, which is one reason the approval starts at age 12. Strong and moderate CYP3A inhibitors must be stopped before starting.
Availability and cost
Only available as the brand-name product.
A specialty oral cancer drug sold by Bristol Myers Squibb. BMS Access Support covers co-pay help for commercially insured patients and refers government-insured patients to independent charities; the BMS Patient Assistance Foundation covers eligible uninsured patients.
Help paying for Augtyro
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
BMS Access Support Co-Pay Assistance Program: eligible commercially insured patients 18 and older may pay as little as $0 per one-month supply, subject to a maximum benefit. Not for Medicare, Medicaid, TRICARE, VA or other government coverage.
For: private insurance · source - Bridge or quick-start supply
Augtyro Bridge Program: if a coverage decision is delayed more than 5 calendar days, enrolled commercially insured patients receive Augtyro at no cost until coverage is received, a denial is appealed, or 2 months, whichever is earlier. One use per lifetime.
For: private insurance · source - Free medicine program
Bristol Myers Squibb Patient Assistance Foundation provides free medication to eligible uninsured patients experiencing financial hardship. Call 800-736-0003 or visit bmspaf.org.
For: no insurance · source - Insurance and case manager help
BMS Access Support provides coverage and access help, co-pay and financial support options, and referrals to independent charitable foundations for government-insured patients.
For: private insurance, Medicare, Medicaid, no insurance, underinsured · source
Good to know: A free trial offer of up to a 29-day supply exists for new commercially insured patients. The co-pay program's dollar cap is not stated in the current BMS terms (04/26).
Access and eligibility
Approved for adults and children 12 and older with solid tumors that have an NTRK gene fusion, are locally advanced or metastatic or where surgery would cause severe harm, and that have progressed after treatment or have no satisfactory alternative. Unlike Vitrakvi and Rozlytrek, prior treatment with another TRK inhibitor is allowed and was studied. Not approved under age 12.
Source: BMS Access Support
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
The NTRK approval is based on 88 adults in the Phase 1/2 TRIDENT-1 trial (NCT03093116). Among 40 patients who had never taken a TRK inhibitor, 58% responded, 15% completely, and 83% of responses were still ongoing at 12 months. Among 48 patients whose tumors had progressed on a prior TRK inhibitor, 50% responded and the median response lasted 9.9 months; in the 25 of those with solvent-front mutations, the response rate was 60%[1]. All 5 patients with measurable brain metastases had intracranial responses. Updated results published in Nature Medicine in February 2026 covered 51 TKI-naive patients (59% response, median progression-free survival 30.3 months) and 69 pretreated patients (48% response, median response duration 9.8 months); 4% stopped the drug for side effects[3]. TRIDENT-1 is still enrolling at 49 US sites, and the CARE study (NCT04094610) is testing repotrectinib in children and young adults up to age 25 at 20 US sites, which could extend the approval below age 12.
Development history
Repotrectinib was developed by Turning Point Therapeutics as TPX-0005, designed to defeat the solvent-front mutations that cause resistance to first-generation TRK and ROS1 inhibitors. Bristol Myers Squibb bought Turning Point in 2022. The FDA first approved Augtyro in November 2023 for ROS1-positive non-small cell lung cancer, then granted accelerated approval on June 13, 2024 for NTRK fusion solid tumors in patients 12 and older[2]. It was the first next-generation TRK inhibitor approved in the United States; zurletrectinib (December 2025) and eratrectinib (June 2026) have since been approved in China.
Explore NTRK Fusion Cancer trials
Other NTRK Fusion Cancer treatments
Common questions about Repotrectinib
▸What is Repotrectinib (Augtyro)?
An oral next-generation TRK inhibitor approved on June 13, 2024 under accelerated approval for adults and children 12 and older with NTRK fusion solid tumors, including tumors that have become resistant to Vitrakvi or Rozlytrek. It is the first US-approved drug that works after a prior TRK inhibitor fails.
▸How does Repotrectinib work?
When a tumor stops responding to a first-generation TRK inhibitor, the usual cause is a new mutation at the entrance of the TRK protein's binding pocket, called a solvent-front mutation, that physically blocks the larger first-generation drugs. Repotrectinib is a smaller, rigid, ring-shaped molecule that still fits past those mutations and shuts the TRK signal off. It also blocks ROS1, which is why it was approved first for ROS1-positive lung cancer, and it crosses into the brain.
▸What are the side effects of Repotrectinib?
The most common side effects in the label (426 patients in TRIDENT-1) were dizziness (65%), altered taste (54%), peripheral neuropathy such as numbness or tingling (49%), constipation (38%), shortness of breath (30%), ataxia, fatigue, cognitive changes and muscle weakness. Nervous system effects of some kind occurred in 77% of patients. The label warns about lung inflammation (interstitial lung disease), liver injury, muscle pain with raised CPK, high uric acid, bone fractures and harm to a fetus. There is no boxed warning.
▸How is Repotrectinib taken?
Taken by mouth: 160 mg once a day for the first 14 days, then 160 mg twice a day, with or without food, until the cancer grows or side effects become unacceptable. It comes as 40 mg and 160 mg capsules only; there is no liquid or pediatric formulation, which is one reason the approval starts at age 12. Strong and moderate CYP3A inhibitors must be stopped before starting.
▸Is Repotrectinib FDA approved?
Yes, Repotrectinib (Augtyro) is FDA approved (2024) for the treatment of NTRK Fusion Cancer.
▸Does Augtyro work after Vitrakvi or Rozlytrek stops working?
Yes, that is its main role. In TRIDENT-1, 50% of 48 patients whose tumors had progressed on a prior TRK inhibitor responded, and the median response lasted 9.9 months. In the 25 patients whose resistance came from a solvent-front mutation, 60% responded. Responses in pretreated patients were shorter than in untreated ones.
▸What is the response rate for Augtyro in NTRK fusion cancer?
In the label, 58% of 40 patients who had never taken a TRK inhibitor responded, with 83% of responses still ongoing at 12 months. In 48 previously treated patients the response rate was 50%. The February 2026 Nature Medicine update reported 59% and 48% in larger groups, with median progression-free survival of 30.3 months in untreated patients.
▸Can children take Augtyro?
Only from age 12. It comes as capsules with no liquid form. The CARE study (NCT04094610) is testing it in children and young adults up to 25 at 20 US sites, which could extend the approval to younger patients.
▸What are the most common side effects of Augtyro?
Dizziness in 65% of patients, altered taste in 54% and numbness or tingling in 49%. Some nervous system effect occurred in 77% of patients, more than with Vitrakvi or Rozlytrek. Most were mild, and the dose is reduced if they become severe.
▸Is Augtyro approved for anything besides NTRK fusion cancer?
Yes. It was first approved in November 2023 for adults with ROS1-positive non-small cell lung cancer, which is a regular approval. The NTRK indication from June 2024 is an accelerated approval that depends on confirmatory results.
▸Does Augtyro reach brain metastases?
It was designed to cross the blood-brain barrier. In the label, all 5 patients with measurable brain metastases had their brain tumors respond.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2024-06-13. Augtyro (repotrectinib) capsules: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb526827-40ba-4462-94cf-179ae3b0cb8a
- U.S. Food and Drug Administration · 2024-06-13. FDA grants accelerated approval to repotrectinib for adult and pediatric patients with NTRK gene fusion-positive solid tumors. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-repotrectinib-adult-and-pediatric-patients-ntrk-gene-fusion-positive
- Nature Medicine · 2026-02-04. Repotrectinib in NTRK fusion-positive advanced solid tumors: a phase 1/2 trial (TRIDENT-1). https://www.nature.com/articles/s41591-025-04079-7
- ClinicalTrials.gov. TRIDENT-1: a study of repotrectinib in patients with advanced solid tumors harboring ALK, ROS1 or NTRK1-3 rearrangements. https://clinicaltrials.gov/study/NCT03093116
- ClinicalTrials.gov. CARE: repotrectinib in pediatric and young adult subjects with advanced or metastatic malignancies harboring ALK, ROS1 or NTRK1-3 alterations. https://clinicaltrials.gov/study/NCT04094610