(Reuters) – The U.S. Food and Drug Administration on Friday approved Daiichi Sankyo Co Ltd’s treatment for adult patients with a type of rare, non-cancerous tumor affecting joints and limbs.
The label for the treatment, Turalio, includes a boxed warning flagging the risk of serious and potentially fatal liver injury.
The decision comes months after independent experts on an advisory panel to the FDA voted in favor of Turalio as a treatment for the debilitating condition called tenosynovial giant cell tumor (TGCT).
Turalio is the first approved therapy in the United States for TGCT, the primary treatment of which has so far been surgery, the agency said.
Daiichi has been focusing on building its oncology business, and the approval comes as a boost after a setback in June when the FDA declined to approve its drug quizartinib as a treatment for adults with a type of blood cancer.
(Reporting by Manojna Maddipatla in Bengaluru; Editing by Sriraj Kalluvila)