Based on its potential to prolong overall survival in patients with Glioblastoma, GBM, Berubicin was granted Fast Track Designation by the American Food and Drug Administration, the FDA, for the treatment of recurrent disease.
Fast Track Designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.
The drug company had previously received Orphan Drug Designation from the FDA for Berubicin.
About Berubicin and the Phase I trial results in Glioblastoma
Berubicin is a novel anthracycline and appears the first of its kind to cross the blood-brain barrier.
This drug has previously demonstrated a antitumor responses including 1 durable complete remission of the disease in a phase 1 trial:
- 44% of patients experienced an improvement in the length of time until the disease worsens.
- One patient experienced a durable complete remission. This is defined as the disappearance of all signs of cancer in response to treatment. This trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.
Patient enrollment was recently initiated for a phase 2 study (NCT04762069) that is investigating the drug versus a standard chemotherapy, Lomustine, as a comparator for the treatment of recurrent GBM.
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Glioblastoma Multiforme, or GBM, is a type of cancer which originates in the brain and made of brain cells known as “gliomas.”
Gliomas are neuron supporting cells, constituting a part of the nervous system.
Glioblastoma tends to develop into a star shaped formation. They are particularly aggressive with the potential to grow fast and spread to other parts of the brain.
Glioblastoma creates its own independent blood supply which feeds it, promoting its growth and even enabling it to invade additional areas of the brain.
GBM is a stage 4 cancer and constitutes about 50% of all brain tumors among patients aged 18 and older. Glioblastoma does not metastasize outside the brain.
The existing therapies used for glioblastoma are not curative, and this is a source of the need for innovative and effective treatment strategies in order to fight the disease.