Treats solid tumors that. NDA 210861, held by Bayer Hlthcare. Larotrectinib Sulfate.
As of Nov 13, 2026, NDA 210861 (Vitrakvi), held by Bayer Hlthcare, was first approved by FDA on Nov 26, 2018, with 5 approved supplements and 0 published complete response letters.
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. Select patients for therapy based on an FDA-approved test.
| Apr 9, 2025 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Nov 26, 2018 | Original applicationNew molecular entity · Priority review | Approved |
| VitrakviEQ 25MG BASE · capsule;oral | Larotrectinib Sulfate | RxReference drug |
| VitrakviEQ 100MG BASE · capsule;oral | Larotrectinib Sulfate | RxReference drug |
| Apr 9, 2025 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Nov 3, 2023 | Supplement 10Labeling · Standard review | Approved | |
| Nov 23, 2022 | Supplement 8Labeling · Standard review | Approved | |
| Mar 25, 2021 | Supplement 4Efficacy (new indication or use) · Standard review | Approved | |
| Mar 25, 2021 | Supplement 6Labeling · Standard review | Approved | |
| Nov 26, 2018 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
