FDA accepts Daiichi Sankyo's pexidartinib for priority review

Japanese drug major Daiichi Sankyo (TYO: 4568) announced that the US Food and Drug Administration has accepted a New Drug Application (NDA) and granted priority review for pexidartinib 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, also referred to as pigmented villonodular synovitis (PVNS) or giant cell tumor of the tendon sheath (GCT-TS), is a non-malignant tumor of the joint or tendon sheath, which can be locally aggressive and debilitating in some patients. There are no currently approved systemic therapies for TGCT.

Under priority review, the FDA aims to take action on an application within six months, as compared to 10 months under standard review. The FDA has designated August 3, 2019 as the action date for this application.