FDA approves Turalio, the first therapy for rare joint tumor

Late on Friday, the US Food and Drug Administration announced it has granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.

The decision comes just a couple of months after the FDA  Oncologic Drugs Advisory Committee voted by a majority of 12 to three in favor of Japanese pharma major Daiichi Sankyo’s (TYO: 4568) pexidartinib. The drug is currently being evaluated by the European Medicines Agency.

Daiichi Sankyo has been focusing on building its oncology business, and the approval comes as a boost after a setback when the same FDA advisory panel voted against approving its drug quizartinib as a treatment for adults with relapsed/refractory FLT3-ITD acute myeloid leukemia (AML), a type of blood cancer.