On 25 July 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional1marketing authorisation for the medicinal product Vitrakvi, intended for the treatment of patients with solid tumours that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The applicant for this medicinal product is Bayer AG.

Vitrakvi will be available as an oral solution (20 mg/ml) and hard capsules (25 and 100 mg). The active substance of Vitrakvi is larotrectinib, a tropomyosin receptor kinase (TRK) inhibitor (ATC code L01XE53). It targets cells with constitutive activation of TRK proteins resulting from gene fusions.

The benefits with Vitrakvi are considered to be its objective response rate and response duration in patients with locally advanced, metastatic solid tumours that display a NTRK gene fusion and who have no satisfactory treatment options. The most common side effects are fatigue, increased alanine transaminase, dizziness, increased aspartate transaminase, constipation, nausea, anaemia, and vomiting.

The full indication is:

“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 (see sections 4.4 and 5.1).”

It is proposed that Vitrakvi be initiated by physicians experienced in the administration of anticancer therapies.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

1A conditional marketing authorisation is granted to a medicinal product that fulfils an unmet medical need when the benefit to public health of immediate availability outweighs the risk inherent in the fact that additional data are still required. The marketing authorisation holder is likely to provide comprehensive clinical data at a later stage.

Key facts

Agency product number
International non-proprietary name (INN) or common name
  • larotrectinib
Active substance
  • larotrectinib sulfate
Therapeutic area
Abdominal Neoplasms

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
Company name
Bayer AG
Application type
Initial authorisation

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