Vitrakvi

RSS

larotrectinib

Authorised
This medicine is authorised for use in the European Union.

Overview

Vitrakvi is a cancer medicine for treating solid tumours with NTRK gene fusion. NTRK gene fusion is a rare genetic abnormality that can occur in tumours from different parts of the body such as the lungs, thyroid glands and intestines.

Vitrakvi is used in patients whose tumours are advanced, have spread to other parts of the body or are not amenable to surgery, and who have no satisfactory alternative treatments.

It contains the active substance larotrectinib.

This EPAR was last updated on 24/10/2019

Authorisation details

Product details
Name
Vitrakvi
Agency product number
EMEA/H/C/004919
Active substance
larotrectinib sulfate
International non-proprietary name (INN) or common name
larotrectinib
Therapeutic area (MeSH)
Abdominal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE53
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approvalConditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Publication details
Marketing-authorisation holder
Bayer AG
Date of issue of marketing authorisation valid throughout the European Union
19/09/2019
Contact address

51368 Leverkusen 
Germany

Product information

19/09/2019 Vitrakvi - EMEA/H/C/004919 -

Contents

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic 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.

Assessment history

How useful was this page?

Add your rating