Quick answers
- What is Larotrectinib used for?
- The FDA-approved label (Vitrakvi, Bayer HealthCare Pharmaceuticals Inc., May 22, 2026) says: “VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Larotrectinib have a boxed warning?
- No. None of the 2 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Larotrectinib?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Larotrectinib been recalled?
- FDA enforcement reports list 1 recall of products of this medicine; the newest started November 6, 2023 (Class I). A recall usually concerns specific lots, not every product.
- Who makes Larotrectinib?
- 2 companies list prescription products of Larotrectinib in the FDA NDC Directory, including Bayer HealthCare Pharmaceuticals Inc. and Loxo Oncology, Inc..
What Larotrectinib is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that: have a neurotrophic receptor tyrosine kinase ( NTRK ) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. …
— FDA label: Vitrakvi, Bayer HealthCare Pharmaceuticals Inc., effective May 22, 2026. Read the full label on DailyMed →
The FDA has 2 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
0 of 2 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Capsule · Solution, concentrate · Solution |
|---|---|
| Route | Oral · Oropharyngeal |
| Prescription products | 7 in the FDA NDC Directory |
| Brand names | Vitrakvi |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- Bayer HealthCare Pharmaceuticals Inc.4 products
- Loxo Oncology, Inc.3 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA210861 VITRAKVI | Bayer Hlthcare | November 26, 2018 | 5, latest April 9, 2025 2025: Efficacy · 2023: Labeling · 2022: Labeling |
| NDA211710 VITRAKVI | Bayer Healthcare | November 26, 2018 | 5, latest April 9, 2025 2025: Efficacy · 2023: Labeling · 2022: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
November 6, 2023 · Class I · Terminated · D-0145-2024
Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicillium brevicompactum observed during routine ongoing stability testing
VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manufactured for Bayer HealthCare Pharmaceuticals Inc., Whippany, NJ 07981. NDC 50419-392-01 — Bayer Healthcare Pharmaceuticals Inc.
What do the recall classes mean?
Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Vitrakvi, Bayer HealthCare Pharmaceuticals Inc., effective May 22, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →