Posted by Michael Wonder on 04 Apr 2019
EMA validates Daiichi Sankyo’s marketing authorisation application for pexidartinib for treatment of patients with TGCT, a rare, debilitating, non-malignant tumour
4 April 2019 - EU marketing authorisation application follows recent filing of the pexidartinib new drug application by the U.S. FDA with priority review.
Daiichi Sankyo announced that the EMA validated the marketing authorisation application for pexidartinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT), which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery. TGCT is also referred to as pigmented villonodular synovitis or giant cell tumour of the tendon sheath.
Validation confirms that the application is complete and commences the scientific review process by the EMA’s CHMP. The EU application is based on results of the pivotal phase 3 ENLIVEN study of oral pexidartinib, the first placebo-controlled study of a systemic investigational therapy in patients with TGCT, which met its primary endpoint of overall response rate. Results of the phase 3 ENLIVEN study were presented during an oral presentation at the 2018 American Society of Clinical Oncology Annual Meeting.
