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NTRK Fusion Cancer Treatments Compared

Name: NTRK Fusion Cancer Treatments Compared
Creator: Jason Hunter
Published: 2026-10-01

3 FDA-approved drugs and 4 in development, side by side from the current prescribing labels. Newest label May 2026. Checked October 1, 2026.

First-generation TRK inhibitorsVitrakvi · Rozlytrek

Next-generation TRK inhibitor (after resistance)Augtyro

Three TRK inhibitors are FDA-approved for solid tumors with an NTRK gene fusion, whatever the tumor type, and all 3 are pills taken at home. Vitrakvi (larotrectinib) is the only one approved solely for NTRK fusion cancer, the only one with full rather than accelerated approval, and the only one with an oral solution and no lower age limit; its label reports a 60% response rate in 339 patients with responses lasting a median of 43.3 months. Rozlytrek (entrectinib) is approved from 1 month of age, also covers ROS1-positive lung cancer, and crosses into the brain, with a 59% response rate in adults and 70% in children. Augtyro (repotrectinib), approved for patients 12 and older, is the only drug approved after a first-generation TRK inhibitor stops working, with a 50% response rate in previously treated patients. In the United States only 2 experimental NTRK drugs are recruiting, TL118 and ANS03, while 2 next-generation drugs approved in China, zurletrectinib and eratrectinib, have no US trials.

Side by side

3 approved NTRK fusion cancer treatments at a glance

How each drug is given, how often, who it is approved for and when it was first approved, from the current FDA label.

NTRK Fusion Cancer treatments compared: route, schedule, approved use and approval date
Drug	How it is given	How often	Approved for	First approved
Vitrakvi larotrectinib Bayer	Capsule or oral solution twice a day at home	100 mg twice daily for body surface area of 1 square meter or more; 100 mg per square meter twice daily for smaller children; continuous until progression	Adults and children of any age with NTRK fusion solid tumors that are metastatic or unresectable, with no good alternative or after progression	November 26, 2018
Rozlytrek entrectinib Genentech (Roche)	Capsule or oral pellets once a day at home	600 mg once daily for adults; children dosed by age and body surface area from 250 mg per square meter; continuous until progression	Adults and children older than 1 month with NTRK fusion solid tumors that are metastatic or unresectable, after progression or with no good alternative (accelerated approval)	August 15, 2019
Augtyro repotrectinib Bristol Myers Squibb	Capsule at home, once a day for 14 days then twice a day	160 mg once daily for 14 days, then 160 mg twice daily; continuous until progression	Adults and children 12 and older with NTRK fusion solid tumors that are locally advanced, metastatic or unresectable, after progression or with no good alternative, including after a prior TRK inhibitor (accelerated approval)	June 13, 2024

The evidence

What the pivotal NTRK fusion cancer trials showed

The primary result from the trial each FDA approval rests on, as reported on the label.

Before you compare

How to read the NTRK fusion cancer trial results

1
The response rates are not a ranking
They come from separate single-arm trials of different sizes and populations: 339 patients for Vitrakvi, 54 adults and 33 children for Rozlytrek, and 88 adults for Augtyro split between people who had never taken a TRK inhibitor (58%) and people whose tumor had already become resistant to one (50%). No trial has compared the drugs head to head, and response rates vary more by tumor type than by drug, from above 90% in infantile fibrosarcoma to below 30% in primary brain tumors.
2
Age and formulation decide the choice for children
Vitrakvi has an oral solution and no age floor, Rozlytrek has sprinkle pellets from 1 month of age, and Augtyro comes only as capsules for patients 12 and older.
3
Approval type matters
Vitrakvi holds full approval since April 2025. The NTRK indications for Rozlytrek and Augtyro are accelerated approvals based on response rate, which the FDA can withdraw if confirmatory data disappoint, though both remain in force as of October 2026.
4
Extra warnings track extra targets
Rozlytrek and Augtyro also block ROS1 and other kinases, which is why Rozlytrek warns about heart failure and QT prolongation and Augtyro about lung inflammation and muscle enzyme rises, and why nervous system side effects are most frequent with Augtyro (77% of patients).

NTRK Fusion Cancer pivotal trial results by drug
Drug	Pivotal trial	Primary result
Vitrakvi larotrectinib Bayer	Pooled LOXO-TRK-14001, SCOUT and NAVIGATE, 339 patients Trial record or paper	60% responded (24% complete), median response duration 43.3 months; 94% in infantile fibrosarcoma, 27% in primary brain tumors
Rozlytrek entrectinib Genentech (Roche)	ALKA, STARTRK-1 and STARTRK-2 (54 adults); STARTRK-NG and TAPISTRY (33 children) Trial record or paper	59% of adults responded (13% complete), 56% of responses lasted 12 months or more; 70% of children responded (42% complete), median response duration 25.4 months
Augtyro repotrectinib Bristol Myers Squibb	TRIDENT-1, 88 adults (40 TRK inhibitor-naive, 48 previously treated) Trial record or paper	58% of untreated patients responded (83% of responses ongoing at 12 months); 50% of previously treated patients responded, median response duration 9.9 months; 60% in those with solvent-front mutations

Safety

NTRK Fusion Cancer treatment side effects and warnings

None of these drugs carries a boxed warning. Each label's main precautions are listed.

NTRK Fusion Cancer treatments: most common side effects and key warnings from the FDA labels
Drug	Most common side effects	Key warning
Vitrakvi larotrectinib Bayer	raised liver enzymes 62%, anemia 45% and musculoskeletal pain 41%	No boxed warning. Nervous system effects (40%), bone fractures (7%), liver injury.
Rozlytrek entrectinib Genentech (Roche)	fatigue 48%, constipation 46% and altered taste 44%	No boxed warning. Heart failure, nervous system effects, fractures, liver injury, QT prolongation, vision changes.
Augtyro repotrectinib Bristol Myers Squibb	dizziness 65%, altered taste 54% and peripheral neuropathy 49%	No boxed warning. Nervous system effects (77%), lung inflammation, liver injury, muscle pain with CPK rise, fractures.

Not yet approved

NTRK fusion cancer treatments in clinical trials or approved only abroad

Investigational drugs in Phase 1 to 3 trials, plus drugs approved by regulators outside the United States, shown separately because their results are not from an FDA label. Status as of the date in each row.

NTRK Fusion Cancer drugs in development
Drug	Status	How it works and is given	Pivotal trial	Result so far	What is next
TL118 Teligene	Phase 2as of October 1, 2026	Oral pan-TRK inhibitor (TRKA, TRKB, TRKC)Oral; dose and schedule not published	NCT06010342, Phase 2, 60 adultsPrimary endpoint: Overall response rate ClinicalTrials.gov	No trial results published yet	Primary completion listed for December 2027; recruiting at MD Anderson, Texas Oncology Dallas and Adventist Health Glendale plus China
ANS03 Avistone Biotechnology	Phase 1as of October 1, 2026	Type II ROS1 and TRK inhibitor that binds the inactive protein, designed for resistance mutationsOral; dose being established	NCT06716138, Phase 1 first-in-human, 96 adults with ROS1 or NTRK alterationsPrimary endpoint: Safety and dose-limiting toxicities ClinicalTrials.gov	No trial results published yet	Recruiting at Memorial Sloan Kettering and sites in China; only preclinical data (AACR April 2025) so far Avistone press release, April 15, 2025
zurletrectinib (ICP-723) InnoCare Pharma	Approved outside the USas of October 1, 2026	Next-generation selective TRK inhibitor, brain-penetrant, active against solvent-front resistance mutationsOral	Registrational trial in China; Phase 1/2 NCT04685226 (310 patients) and Phase 2 basket from age 2 NCT05745623 still recruitingPrimary endpoint: Overall response rate ClinicalTrials.gov	89.1% overall response rate, 96.4% disease control, 77.4% progression-free at 24 months (InnoCare, 2025-12-11)	Approved in China December 11, 2025 for age 12 and older; pediatric application under priority review since March 2026; no US filing announced InnoCare press release, December 11, 2025
eratrectinib (VC004, Velmarto) Jiangsu Vcare PharmaTech	Approved outside the USas of October 1, 2026	Next-generation selective TRK inhibitor designed to overcome first-generation resistanceOral	VC004-101 pivotal trial in China; single-arm Phase 3 NCT06658353 (54 patients) recruitingPrimary endpoint: Overall response rate ClinicalTrials.gov	68.5% overall response rate (89.7% with more than 6 months follow-up), 75.7% progression-free at 2 years, median survival 40.7 months (Vcare, 2026-08-12)	Approved in China June 2026; companion diagnostic approved August 6, 2026; not studied in the US Vcare news, August 12, 2026

Cost

Help paying for NTRK fusion cancer treatment

Drugmaker copay and free-drug programs, plus charity funds for the condition, checked every week.

Questions

NTRK Fusion Cancer treatment questions people ask

Which TRK inhibitor is best for NTRK fusion cancer?

No trial has compared them, so there is no proven best. Vitrakvi and Rozlytrek are both first-line options with response rates near 60% in adults; Vitrakvi is NTRK-specific with full approval and an oral solution for infants, while Rozlytrek has stronger brain penetration data and starts at 1 month of age. Augtyro is the choice once a tumor becomes resistant to either, and can also be used first in patients 12 and older.

What happens when Vitrakvi or Rozlytrek stops working?

Most resistance comes from new mutations in the NTRK gene, especially solvent-front mutations, that block the first-generation drugs from binding. Augtyro (repotrectinib) was designed to fit past those mutations and is approved for patients 12 and older after a prior TRK inhibitor; 50% of such patients responded in TRIDENT-1, including 60% of those with solvent-front mutations, with responses lasting a median of 9.9 months.

Can a baby with infantile fibrosarcoma take a TRK inhibitor?

Yes. Vitrakvi has no lower age limit and comes as a 20 mg/mL oral solution dosed by body surface area; its label reports a 94% response rate in 49 patients with infantile fibrosarcoma. Rozlytrek is approved from 1 month of age as oral pellets and reported responses in 7 of 8 children with infantile fibrosarcoma. Augtyro is not approved under age 12.

Are there clinical trials for NTRK fusion cancer in the United States?

As of October 2026, 2 investigational drugs are recruiting at US sites: TL118, a Phase 2 pan-TRK inhibitor at MD Anderson, Texas Oncology in Dallas and Adventist Health in Glendale (NCT06010342), and ANS03, a Phase 1 type II ROS1 and TRK inhibitor at Memorial Sloan Kettering (NCT06716138). The approved drugs are also in US trials for new settings, including the CARE study of Augtyro in children under 12 (NCT04094610) and GLOBOTRK, a St. Jude study of Rozlytrek as first treatment for infants with NTRK-fused brain tumors (NCT06528691).

Is zurletrectinib available in the United States?

No. Zurletrectinib (InnoCare) was approved in China on December 11, 2025 with an 89.1% response rate in its registrational trial, and eratrectinib (Vcare) was approved in China in June 2026 with a 68.5% response rate. Neither has a US filing or a US trial that is recruiting, so US patients cannot get them.

Which NTRK fusion drugs are fully approved?

Only Vitrakvi. The FDA converted its 2018 accelerated approval to full approval on April 9, 2025. Rozlytrek's NTRK indication (2019, extended to infants in 2023) and Augtyro's (June 2024) remain accelerated approvals that depend on confirmatory data.

Go deeper

More on NTRK Fusion Cancer at Trial Friend

Sources

Where every number on this page comes from

Approved-drug facts are from the current FDA prescribing information on DailyMed, with the label's effective date. Investigational-drug facts are from ClinicalTrials.gov and the sources named in each row.

Vitrakvi (larotrectinib) prescribing information, Bayer, label dated May 2026. DailyMed. Pivotal trial: ClinicalTrials.gov
Rozlytrek (entrectinib) prescribing information, Genentech (Roche), label dated Dec 2025. DailyMed. Pivotal trial: ClinicalTrials.gov
Augtyro (repotrectinib) prescribing information, Bristol Myers Squibb, label dated Jun 2024. DailyMed. Pivotal trial: ClinicalTrials.gov
TL118, Teligene: ClinicalTrials.gov record. Checked October 1, 2026.
ANS03, Avistone Biotechnology: ClinicalTrials.gov record; Avistone press release, April 15, 2025. Checked October 1, 2026.
zurletrectinib (ICP-723), InnoCare Pharma: ClinicalTrials.gov record; InnoCare press release, December 11, 2025. Checked October 1, 2026.
eratrectinib (VC004, Velmarto), Jiangsu Vcare PharmaTech: ClinicalTrials.gov record; Vcare news, August 12, 2026. Checked October 1, 2026.

This page compares what the FDA labels and pivotal trials report. It is not medical advice, and no trial on this page compared these drugs with each other. Written and checked by Jason Hunter; the method is on the editorial standards page.