The FDA has approved Turalio, the first therapy for adult patients with a rare, nonmalignant tumor that affects joints and causes severe morbidity.
The treatment, designated as a breakthrough therapy by the FDA, supports patients with symptomatic tenosynovial giant cell tumors that didn't respond to surgery.
Surgery is the primary treatment option, but some patients are not eligible for surgery or have tumors reappear after surgery.
Turalio, made by Basking Ridge, N.J.-based Daiichi Sankyo, comes with a warning about the risk of serious liver toxicity.