FDA grants fast track status to enzastaurin for newly diagnosed glioblastoma
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The FDA granted fast track designation to enzastaurin for the treatment of patients with newly diagnosed glioblastoma, according to a press release from the agent’s manufacturer.
Enzastaurin (DB102, Denovo Biopharma) is an orally available, investigational first-in-class small molecule serine/threonine kinase inhibitor of the PKC beta, PI3K and AKT pathways.
Data suggest the addition of high-dose enzastaurin to temozolomide may improve outcomes among patients with glioblastoma who have the DGM1 biomarker, regardless of MGMT methylation status. The manufacturer plans a randomized phase 3 trial of enzastaurin with temozolomide during and following radiotherapy among patients newly diagnosed with glioblastoma.
“This fast track designation in glioblastoma is an important milestone in the development of DB102,” Xiao-Xiong Lu, PhD, Denovo's chief technical officer, said in the release. “We are pleased that FDA has recognized our innovative biomarker approach to conquer glioblastoma. It potentially accelerates our development of DB102 in glioblastoma, a difficult-to-treat indication with a significant unmet need, and adds value to our DB102 franchise.”
Enzastaurin — which has been studied in more than 3,000 patients with a range of solid tumors and hematologic cancers — also has received orphan drug designation for glioblastoma and diffuse large B-cell lymphoma.
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