Research & Development
Biologics by McKesson reports launch of TURALIO (pexidartinib) for tenosynovial giant cell tumor
8 August 2019 -

Specialty pharmacy Biologics by McKesson reported on Wednesday that it has been selected by Daiichi Sankyo Inc as the exclusive specialty pharmacy provider for TURALIO (pexidartinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) 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 US Food and Drug Administration (FDA) on 2 August 2019.

In February 2019, the US FDA accepted, with Priority Review, a New Drug Application (NDA) for TURALIO based on results of Biologics by McKesson's phase 3 ENLIVEN study, the first placebo-controlled study of a systemic investigational therapy in patients with TGCT.

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. Treatment options are limited for these patients because there are no approved systemic therapies for the disease.