Tokyo and Munich – (June 26, 2020) – Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT). The European marketing authorization application was based on results of the pivotal phase 3 ENLIVEN study, which were published in The Lancet on June 19, 2019.[1]
A committee of the European Medicines Agency (EMA) recommended that eight new medicines be approved at its June meeting, and issued a negative opinion on an anti-tumor drug.
TOKYO & MUNICH--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on the Marketing Authorization Application (MAA) for pexidartinib for the treatment of a subset of adult patients with severe tenosynovial giant cell tumor (TGCT). The European marketing authorization application was based on results of the pivotal phase 3 ENLIVEN study, which were published in The Lancet on June 19, 2019.1
Daiichi Sankyo finally has a regulatory win to celebrate as the FDA sanctions a careful, restricted rollout of pexidartinib, to be marketed as Turalio.
Daiichi Sankyo has seen its CSF1R inhibitor Turalio (pexidartinib) approved by the FDA in the treatment of symptomatic tenosynovial giant cell tumours (TGCT) in adult patients whose disease is associated with severe morbidity or functional limitations and cannot be improved with surgery, making it the first and only therapy available in the US for this indication.
Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
Today, the U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.
TURALIO is the first and only approved therapy for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery
Daiichi Sankyo Company, Limited , today announced that new data from a pooled analysis of the phase 3 ENLIVEN study and phase 1 extension study showed continued treatment with pexidartinib resulted in an increased tumor response rate in TGCT patients. The data will be presented during a Poster Session on Saturday, June 1, at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract #11042; 8:00-11:00 a.m. CDT).
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (Vote: 12 yes, 3 no, zero abstained) that the demonstrated benefit of pexidartinib outweighs the risks in the treatment of adult patients with symptomatic TGCT, which is associated with severe morbidity or functional limitations, and which is not amenable to improvement with surgery.