EMA recommends approval for first ‘histology-independent’ cancer treatment in EU


  • Mary Corcoran
  • Univadis Medical News
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The European Medicines Agency’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation for larotrectinib (Vitrakvi) for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. 

Conditional approval of a medicine allows the Agency to recommend a medicine for marketing authorisation with less complete data than normally expected, in cases where the benefit of a medicine’s immediate availability to patients outweighs the risk inherent in the fact that not all the data are yet available.

Vitrakvi is the first ‘histology-independent’ cancer treatment recommended for approval in the European Union and is indicated for patients 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. 

The efficacy and safety of the treatment were studied in three single-arm trials including a total of 102 adults and children with cancer, with 67 per cent of patients responding to treatment. Of those, the response lasted six months or longer in 88 per cent and 12 months or longer in 75 per cent.

The most common side effects are fatigue, increased alanine transaminase, dizziness, increased aspartate transaminase, constipation, nausea, anaemia and vomiting.