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.
Hansa Biopharma submits imlifidase Biologics License Application to FDA
T-MAXIMUM Pharmaceutical receives IND approval to start Phase II trial of MT027 for rGBM
Alvotech and Teva secure US launch date for Eylea biosimilar AVT06
Egetis initiates rolling US NDA for Emcitate in MCT8 deficiency
Abbott's Amplatzer Piccolo Delivery System receives US FDA clearance and CE Mark
Amphix Bio announces initial closing of USD12.5m seed financing round
BiBBInstruments reports additional US orders during targeted EndoDrill GI launch
Sanofi's efdoralprin alfa receives EU orphan designation for AATD-related emphysema
Black Buffalo partners with Sanova to support regulatory strategy and scientific innovation
Nicox completes key data package for NCX 470 NDA submissions
Immusoft's ISP-002 granted US FDA Orphan Drug Designation in MPS II
Orphan Therapeutics Accelerator signs MoU with Fondazione Telethon
Bioretec wins FDA breakthrough status for biodegradable orthopaedic DrillPin
Amferia raises EUR3.5m to advance antimicrobial wound-care platform
Sobi s Aspaveli marketing authorisation receives positive European regulatory opinion