Closely-held Denovo Biopharma’s DB102 received FDA fast track designation for the treatment of patients with newly-diagnosed glioblastoma.
DB102, or enzastaurin, is a small molecule, serine/threonine kinase inhibitor originally developed by Eli Lilly (NYSE:LLY), from which Denovo acquired worldwide rights.
Denovo plans to conduct a Phase 3 study of DB102 in combination with temozolomide, both during and following radiation therapy.
“This fast track designation in glioblastoma is an important milestone in the development of DB102,” Xiao-Xiong Lu, Denovo’s chief technical officer, said in a statement.
“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,” he added.
DB102 has received FDA and EMA orphan drug designation for diffuse large B-cell lymphoma and glioblastoma multiforme.
