EMA validates Daiichi Sankyo's application for pexidartinib

The European Medicines Agency has validated the Marketing Authorization Application (MAA) for pexidartinib.

Under development by Japan’s Daiichi Sankyo (TYO: 4568), pexidartinib is intended for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (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 villonodularsynovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS). Validation confirms that the application is complete and commences the scientific review process by the EMA’s Committee for Medicinal Products for Human Use (CHMP).