...La Thangue said it will likely be placebo-controlled.There is one FDA-approved therapy for TGCT: Turalio pexidartinib...

...with transfusion-dependent anemia. Elizabeth S. Eaton, Staff Writer Veklury, remdesivir (GS-5734) Reblozyl, luspatercept-aamt (ACE-536) IdeS, imlifidase Trikafta, elexacaftor/tezacaftor/ivacaftor (VX-445/VX-661/VX-770) Turalio, pexidartinib (PLX3397) Xiidra...

...FDA approves Daiichi's pexidartinib FDA approved Turalio pexidartinib from Daiichi Sankyo Co. Ltd. (Tokyo:4568) to treat...
...colony-stimulating factor 1 receptor (C-FMS) Consensus estimates provided by FactSet. BioCentury Staff Elzonris (tagraxofusp-erzs, SL-401) Inbrija (CVT-301) pexidartinib (PLX3397) Vimizim...

...split. The efficacy and lack of available treatments swayed the panel to support approval of pexidartinib...
...second trial of the AML candidate (see "Daiichi Gets ODAC Split, with FDA Panel Backing Pexidartinib...
...HER3 (ERBB3;EGFR3) - Erb-b2 receptor tyrosine kinase 3 TOP1 - Topoisomerase I Erin McCallister, Senior Editor pexidartinib (PLX3397) quizartinib...

...options for tenosynovial giant cell tumor and a clear win on the primary endpoint for pexidartinib...
...as well, with the Oncologic Drugs Advisory Committee snubbing the compound with a 3-8 vote. Pexidartinib...
...tyrosine kinase (c-Kit; KIT; CD117); CSF1R - colony-stimulating factor 1 receptor (C-FMS) Erin McCallister, Senior Editor pexidartinib (PLX3397) quizartinib...

...FDA reviewers raise concerns about Daiichi’s quizartinib, pexidartinib Despite both pexidartinib and quizartinib meeting the primary...
...documents posted ahead of a May 14 meeting of FDA’s Oncologic Drugs Advisory Committee. For pexidartinib...
...Staff Writer, and Erin McCallister, Senior Editor Descovy (Brand), emtricitabine/tenofovir alafenamide (Generic), F/TAF (Informal), Descovy (Other) pexidartinib (PLX3397) quizartinib...

...Committee will meet on May 14 to discuss two NDAs from Daiichi Sankyo, one for pexidartinib...
...quizartinib to treat relapsed or refractory FLT3-internal tandem duplication (ITD) mutation-positive acute myelogenous leukemia (AML). Pexidartinib...
...“Daiichi’s AML Candidate Leads to Median OS of 6.2 Months” ; “Daiichi Planning NDA for Pexidartinib...

...tenosynovial giant cell tumors (TGCT) in the Phase III ENLIVEN trial showing that oral pexidartinib (PLX3397...
...an NDA to FDA for pexidartinib in the indication, but declined to disclose a timeline. Pexidartinib...
...U.S. and EU to treat TGCT. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Pexidartinib (PLX3397...

...inhibitors in the clinic for cancer. The most advanced is Daiichi Sankyo Co. Ltd.’s pexidartinib (PLX3397...
...a greater reduction in tumor volume in a syngeneic mouse model of breast cancer than pexidartinib...

...Daiichi Sankyo Co. Ltd. (Tokyo:4568) said oral pexidartinib (PLX3397) met the primary endpoint of reducing tumor...
...of response. Daiichi said an ongoing comprehensive benefit-risk evaluation for the indication based on its pexidartinib...
...Phase II testing to treat glioblastoma. Daiichi Sankyo Co. Ltd. (Tokyo:4568), Tokyo, Japan Product: Pexidartinib (PLX3397...