Biologics by McKesson has been selected by Daiichi Sankyo as the exclusive specialty pharmacy provider for TURALIO™ (pexidartinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery.
TURALIO, a first-in-class oral tyrosine kinase inhibitor for TGCT, was approved by the FDA on August 2, 2019. Surgery is the primary mode of treatment for TGCT associated with severe morbidity or functional limitations; however, some patients have disease that is not amenable to resection. In February 2019, the FDA accepted, with Priority Review, a New Drug Application (NDA) for TURALIO based on results of the phase 3 ENLIVEN study, the first placebo-controlled study of a systemic investigational therapy in patients with TGCT.
TURALIO is approved with a Boxed Warning for the risk of serious and potentially fatal liver injury. Hepatotoxicity with ductopenia and cholestasis has occurred in patients treated with TURALIO. Across 768 patients who received TURALIO in clinical trials, there were two irreversible cases of cholestatic liver injury. One patient died with advanced cancer and ongoing liver toxicity, and one patient required a liver transplant. The mechanism of cholestatic hepatotoxicity is unknown, and its occurrence cannot be predicted. It is unknown whether liver injury occurs in the absence of increased transaminases.
“We are pleased to be able to dispense this first systemic therapy for TGCT to patients,” said Ann Steagall, director of Clinical Policy, Biologics by McKesson. “It offers patients a treatment where surgery may not be an option. We’re excited to support TGCT patients as well as distribute another therapy in our growing portfolio of complex care. Due to the risk of serious and potentially fatal hepatotoxicity, TURALIO is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. As a leading provider of risk assessment and care planning, Biologics is proud to help ensure that patients taking TURALIO get the level of care they need and deserve.”