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.

Vitrakvi is available as a liquid (20 mg per ml) and capsules (25 and 100 mg) and is taken by mouth. Adult patients should take 100 mg twice a day for as long as the cancer is stable and the side effects are acceptable. The dose for children is based on their body surface area (weight and height).

Vitrakvi should be started by a doctor experienced in using cancer medicines and can only be obtained with a prescription. For more information about using Vitrakvi, see the package leaflet or contact your doctor or pharmacist.

Tumours with NTRK gene fusion produce an abnormal protein (TRK fusion protein), which causes the uncontrolled growth of cancer cells. The active substance in Vitrakvi, larotrectinib, blocks the action of this protein, preventing the excessive growth of cancer cells and thereby slowing down the worsening of the cancer.

Three ongoing studies in 102 patients with solid tumours with NTRK gene fusion showed that Vitrakvi is effective at reducing the size of patients’ tumours. In these studies, 67% of patients who took Vitrakvi had a reduction in the size of their tumours, and the tumours on average shrank to less than half their original size. In addition, the tumours shrank quickly (within 2 months).

The most common side effects with Vitrakvi (which may affect more than 1 in 5 people) are tiredness, dizziness, constipation, nausea, vomiting, anaemia (low red blood cell counts) and high blood levels of alanine aminotransferase and aspartate aminotransferase (a sign of liver problems).

Most side effects are mild to moderate. For the full list of side effects and restrictions, see the package leaflet.

Vitrakvi differs from many other cancer medicines by targeting certain tumours with a specific gene arrangement wherever they occur in the body. Although studies are still underway, the results released so far show that it is effective at reducing the size of patients’ tumours. In addition, the short time taken to shrink the tumours is important in relieving patients’ symptoms.

As for its safety, the side effects of Vitrakvi appear manageable. The European Medicines Agency therefore concluded that its benefits are greater than its risks and that it can be authorised for use in the EU.

Vitrakvi has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

Since Vitrakvi has been given conditional authorisation, the company that markets Vitrakvi will provide further data on its effects. This data will come from the three ongoing studies which aim to confirm the benefits and safety of Vitrakvi and its longer term effect in children.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vitrakvi have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Vitrakvi are continuously monitored. Side effects reported with Vitrakvi are carefully evaluated and any necessary action taken to protect patients.

Vitrakvi received a conditional marketing authorisation valid throughout the EU on 19 September 2019.

Vitrakvi : EPAR - Medicine overview

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Vitrakvi : EPAR - Risk-management-plan summary

Product information

Vitrakvi : EPAR - Product information

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Latest procedure affecting product information: II/0030

16/08/2023

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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

Vitrakvi : EPAR - All authorised presentations

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Product details

Name of medicine
Vitrakvi
Active substance
larotrectinib sulfate
International non-proprietary name (INN) or common name
larotrectinib
Therapeutic area (MeSH)
Abdominal Neoplasms
Anatomical therapeutic chemical (ATC) code
L01XE53

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.

Authorisation details

EMA product number
EMEA/H/C/004919

Additional 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 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.

Marketing authorisation holder
Bayer AG

51368 Leverkusen 
Germany

Opinion adopted
25/07/2019
Marketing authorisation issued
19/09/2019
Revision
10

Assessment history

Vitrakvi : EPAR - Procedural steps taken and scientific information after authorisation

Vitrakvi-H-C-004919-P46-008 : EPAR - Assessment report

Vitrakvi : Orphan designation withdrawal assessment report (initial authorisation)

Vitrakvi : EPAR - Public assessment report

CHMP summary of positive opinion for Vitrakvi

Topics

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