Vitrakvi (larotrectinib)
ConditionalAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- larotrectinib
- Company
- Bayer AG
- Status
- Authorised
- Therapeutic area
- Abdominal Neoplasms
- CHMP opinion
- Thu 25 Jul 2019
- EU approval
- Thu 19 Sep 2019
- Designations
- Conditional, Additional monitoring
- Application
- EMEA/H/C/004919
- ATC
- L01XE53
- Official record
- www.ema.europa.eu
Indication
Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
Regulatory milestones
No milestones recorded in the last year.
Follow Vitrakvi
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.