Berubicin Receives FDA Fast Track Designation for Recurrent Glioblastoma Multiforme

The FDA has granted fast track designation to the investigational drug berubicin for the treatment of patients with recurrent glioblastoma multiforme. This designation follows an orphan drug designation for the same indication.

Glioblastoma is the most aggressive, deadly, and treatment-resistant form of cancer in the brain, according to a press release from CNS Pharmaceuticals. Many patients with this diagnosis have almost no meaningful treatment options and thousands of patients die each year. Because of this, the approval of berubicin could have a significant impact on the treatment landscape.

Berubicin is an anthracycline designed to use natural processes to induce DNA damage in targeted cancer cells by interfering with topoisomerase II, which enables cell proliferation. Anthracyclines are some of the most powerful chemotherapies available and are effective against more types of cancer than any other class of chemotherapeutic agents, according to the press release.

Patients treated with berubicin in clinical trials appeared to demonstrate positive responses, including 1 durable complete response in a phase 1 human clinical trial, according to the press release. Researchers with CNS Pharmaceuticals recently announced the beginning of patient enrollment in its study of berubicin for the treatment of recurrent glioblastoma multiforme.

The fast track designation enables the company to have more frequent interactions with the FDA in order to expedite the development and review process. It is granted to drugs that are intended to treat serious or life-threatening conditions and that have the potential to address significant unmet medical needs.

REFERENCE

WPD Pharmaceuticals’ Licensor Receives FDA Fast Track Designation for Berubicin for the Treatment of Recurrent Glioblastoma Multiforme; WPD Poland Arranges Loans. News release. WPD Pharmaceuticals. July 12, 2021. Accessed July 21, 2021. https://www.globenewswire.com/news-release/2021/07/12/2261091/0/en/WPD-Pharmaceuticals-Licensor-Receives-FDA-Fast-Track-Designation-for-Berubicin-for-the-Treatment-of-Recurrent-Glioblastoma-Multiforme-WPD-Poland-Arranges-Loans.html