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.
Futura Medical reports positive home user test results for Eroxon and Intense variant
GSK secures Japan Orphan Drug status for lung cancer ADC
Belief BioMed enters exclusive partnership with Grand Life Sciences for haemophilia A treatment
Glaukos launches Epioxa to advance incision-free treatment for keratoconus
Sanofi's venglustat receives FDA Breakthrough Therapy designation for type 3 Gaucher disease
Sentynl Therapeutics and PRG S&T enter licensing agreement for potential HGPS treatment
CMIC agrees agentic AI partnership with Bluenote
Biofrontera reports Phase 2b data for Ameluz photodynamic therapy in acne vulgaris treatment
Precision BioSciences receives FDA Fast Track designation for PBGENE-DMD
Egetis receives US notice of allowance for MCT8 deficiency composition patent
Ipsen withdraws tazverik across all markets following safety concerns in lymphoma trial
Foresee Pharmaceuticals receives positive CHMP opinion for CAMCEVI 21 mg
Great Novel Therapeutics' GNTbm-38 approved by US FDA for Phase I trial