FDA grants fast track designation to berubicin for recurrent glioblastoma
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The FDA granted fast track designation to berubicin for the treatment of recurrent glioblastoma multiforme, according to the agent’s manufacturer.
Berubicin (CNS Pharmaceuticals) is a novel anthracycline that showed the ability in a phase 1 trial to induce positive responses among patients with brain cancer. One patient achieved durable complete response.
“Receiving fast track designation ... is a huge achievement in our advancement of berubicin for the treatment of glioblastoma, the most aggressive, deadly and treatment-resistant type of cancer that forms in the brain,” John Climaco, CEO of CNS Pharmaceuticals, said in a company-issued press release. “If there were ever a disease where the unmet clinical need demands action, it is glioblastoma multiforme. Patients have almost no meaningful options and thousands lose their fight against this terrible cancer every year. With this designation, we now have an accelerated pathway to approval for berubicin and a clear opportunity to more expediently bring this potentially impactful investigational therapy to individuals battling this challenging disease.”
Enrollment is underway for a potentially pivotal study of berubicin for treatment of recurrent glioblastoma multiforme.
The FDA previously granted orphan drug designation to berubicin for the same indication.
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