Orphan Status for Ibrutinib
Ibrutinib has been granted an orphan designation by the European Medicines Agency for the treatment of follicular lymphoma (FL).
Results from early studies in patients with FL indicated that ibrutinib may improve outcomes in patients whose disease has recurred or is no longer responding to treatment. The orphan designation requires additional studies be undertaken to demonstrate the therapy’s quality, safety and efficacy before marketing authorisation can be granted. For more information, click here.