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Marketing authorisation with orphan designation - USA

  • Tradename: VITRAKVI
  • ATC code : L01XE53
  • EU Number: -
  • MA date : 26/11/2018

Therapeutic indication

Treatment of adult and pediatric patients with solid tumors that:
* have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation,
* are metastatic or where surgical resection is likely to result in severe morbidity, and
* have no satisfactory alternative treatments or that have progressed following treatment.
This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

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