Latest for NTRK Fusion Cancer
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- Trial statusNo longer enrolling. Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI… (Bayer)ClinicalTrials.gov
More about NTRK Fusion Cancer
The breakthrough in NTRK fusion cancer treatment came with the FDA approvals of larotrectinib (Vitrakvi, Bayer) in November 2018 and entrectinib (Rozlytrek, Roche/Genentech) in August 2019, the first targeted kinase inhibitors approved for a molecular marker rather than a tumor location (pembrolizumab had been approved tissue-agnostically for MSI-high tumors in 2017, so the FDA counts larotrectinib as the second tissue-agnostic approval).
Keep reading about NTRK Fusion Cancer
Larotrectinib, originally developed by Loxo Oncology (acquired by Eli Lilly in February 2019), is a highly selective TRK inhibitor.
The first published analysis of 55 patients reported a 75% response rate across 17 tumor types; the current label, based on 339 patients, reports a 60% response rate with 24% complete responses and a median response duration of 43.3 months, with rates ranging from 94% in infantile fibrosarcoma to 27% in primary brain tumors. Larotrectinib received full FDA approval on April 9, 2025, converting from its 2018 accelerated approval.
Bayer holds exclusive global commercial rights to Vitrakvi, which is the only one of the 3 drugs with an oral solution and no lower age limit. Entrectinib (Rozlytrek) is approved under accelerated approval for NTRK fusion solid tumors in patients older than 1 month, as well as for ROS1-positive lung cancer; it crosses into the brain and reported a 59% response rate in adults and 70% in children.
On June 13, 2024, repotrectinib (Augtyro, Bristol Myers Squibb) received accelerated approval for NTRK fusion solid tumors in patients 12 and older, the first next-generation TRK inhibitor approved in the United States and the only approved option for tumors that have become resistant to larotrectinib or entrectinib, with a 50% response rate in previously treated patients.
Two further next-generation TRK inhibitors, zurletrectinib (December 2025) and eratrectinib (June 2026), have been approved in China but not in the United States. Comprehensive genomic profiling (CGP) through next-generation sequencing is essential for identifying patients who may benefit from these targeted therapies, and immunohistochemistry for the TRK protein is used as a screening test in some tumor types.
What are the symptoms of NTRK Fusion Cancer?
These are common symptoms of NTRK Fusion Cancer, and how strong they are varies from person to person.
- Symptoms vary widely depending on the tumor type and location
- A growing lump or mass that may or may not be painful
- Fatigue and unexplained weight loss
- Pain in the affected area
- Organ-specific symptoms depending on tumor location
- Some NTRK fusion tumors are found incidentally on imaging
Who gets NTRK Fusion Cancer?
NTRK fusions can occur at any age, from infants to older adults. They have been identified across more than 2 dozen tumor types. Some cancers like infantile fibrosarcoma and secretory breast carcinoma have very high rates of NTRK fusions, while common cancers like lung and colon cancer have them rarely. No clear ethnic or gender predisposition for the fusion itself.
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Which medicines are FDA-approved for NTRK Fusion Cancer?
There are currently 3 FDA-approved medications for NTRK Fusion Cancer.
Source: openFDA drug labeling data. This list may not include all treatments. Always consult your doctor.
Which new NTRK Fusion Cancer medicines are in trials?
Investigational medicines Trial Friend tracks for NTRK Fusion Cancer, with trial results, safety findings and where each one stands.
How to get help paying for NTRK Fusion Cancer treatment
Charity funds and drugmaker programs for NTRK Fusion Cancer, checked at the source.
- Vitrakvi (Larotrectinib) · Access Services by Bayer (TRAK Assist)
- Rozlytrek (Entrectinib) · Rozlytrek Access Solutions (Genentech)
- Augtyro (Repotrectinib) · BMS Access Support
Every program and fund for NTRK Fusion Cancer, by insurance →
Side effects people have reported to the FDA
Side effects people have reported to the FDA
Real-world side effect reports from the FDA Adverse Event Reporting System (FAERS). Includes both FDA-approved drugs and investigational therapies from active clinical trials. Click any drug to see what patients reported.
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Diagnosis and genetic testing
Genetic testing for NTRK Fusion Cancer
Genetic testing can confirm a diagnosis, guide treatment decisions, and identify family members who may be at risk.
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Trusted NTRK Fusion Cancer resources
Reputable organizations and medical references for learning more about NTRK Fusion Cancer, including disease registries, foundation resources, and clinical guidelines.
- NCI Cancer Currents: FDA approves entrectinib based on tumor genetics rather than cancer type
- FDA: approval of larotrectinib for solid tumors with NTRK gene fusions (Nov 26, 2018)
- FDA: Cancer Accelerated Approvals, Other (Vitrakvi full approval April 9, 2025)
- FDA: accelerated approval of repotrectinib for NTRK gene fusion-positive solid tumors (June 13, 2024)
- FDA: pediatric indication expansion for entrectinib and pellet formulation (Oct 20, 2023)
- DailyMed: Vitrakvi (larotrectinib) prescribing information
- DailyMed: Rozlytrek (entrectinib) prescribing information
- DailyMed: Augtyro (repotrectinib) prescribing information
- Drilon et al., Efficacy of larotrectinib in TRK fusion-positive cancers in adults and children, NEJM 2018
- Cocco, Scaltriti and Drilon, NTRK fusion-positive cancers and TRK inhibitor therapy, Nature Reviews Clinical Oncology 2018
- Solomon et al., Repotrectinib in NTRK fusion-positive advanced solid tumors (TRIDENT-1), Nature Medicine 2026
- NTRKers patient community