Posted by Michael Wonder on 17 Jul 2020
FDA grants fast track designation for DB102 in patients with newly diagnosed glioblastoma
17 July 2020 - Denovo Biopharma today announced that the U.S. FDA has granted fast track designation for DB102 (enzastaurin) being developed for the potential treatment of patients with newly diagnosed glioblastoma.
Despite numerous attempts by many drug companies, GBM remains one of the deadliest cancers and the first line drug treatment still relies on temozolomide as the backbone. Many promising anticancer drugs, including anti-PD-1 drugs, failed to surpass temozolomide's efficacy. With Denovo's newly discovered DGM1 biomarker, it was found that the addition of enzastaurin may improve outcomes in glioblastoma patients who possess the DGM1 biomarker and are exposed to a high dose of DB102, regardless of MGMT methylation status.
Denovo plans to conduct a randomised, double-blind, placebo-controlled Phase 3 pivotal study of enzastaurin in combination with temozolomide, both during and following radiation therapy, in newly-diagnosed glioblastoma patients.
