Blueprint Medicines announces European Medicines Agency validation of marketing authorisation application for avapritinib for the treatment of PDGFRα D842V mutant GIST and fourth-line GIST

Blueprint Medicines

18 July 2019 - Blueprint Medicines Corporation today announced that the EMA has validated the company's marketing authorisation application for avapritinib for the treatment of adult patients with PDGFRα D842V mutant gastro-intestinal stromal tumours, regardless of prior therapy, and fourth-line gastro-intestinal stromal tumour.

Validation of the application confirms that the application is sufficiently complete to begin the formal review process. Avapritinib is an investigational, potent and highly selective KIT and PDGFRA inhibitor for patients with advanced gastro-intestinal stromal tumour (GIST).

The European Commission has granted orphan medicinal product designation to avapritinib for the treatment of GIST.

Read Blueprint Medicines press release


Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Dossier