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EMA recommends Vitrakvi for EU marketing authorisation

The EMA has announced its approval for marketing authorisation in the EU for Vitrakvi (larotrectinib), used to treat solid tumours with a specific gene mutation.

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has announced its approval of marketing authorisation in the EU for Vitrakvi (larotrectinib). The drug is for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion.

Treatment with the Vitrakvi, produced by Bayer AG, is recommended for patients whose disease has spread or cannot be surgically removed and who have no other satisfactory treatment options. The drug is the first ‘histology-independent’ cancer treatment recommended for approval in the EU.

The active substance of larotrectinib in Vitrakvi targets a specific genomic alteration of a patient’s tumour. This occurs when NTRK genes that encode specific proteins are abnormally fused to a gene. This mutation leads to the development of proteins that can cause cancer cells to grow. Vitrakvi blocks the action of these proteins and so inhibits the growth of the cancer.

The efficacy and safety of Vitrakvi was studied in three single-arm trials that included a total of 102 adults and children with cancer. These patients had either already received standard therapy, or would have had to undergo disfiguring surgery, or were unlikely to respond to available therapies.

The drug is the first ‘histology-independent’ cancer treatment recommended for approval in the EU

The CHMP recommended a conditional approval for this medicine, one of the EU’s regulatory mechanisms to facilitate early access to medicines that fulfil an unmet medical need. This type of approval 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.

The opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.

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