FDA grants ODD to ABM Therapeutics’ treatment for patients with glioblastoma
Betsy Goodfellow | August 3, 2023 | News story | Medical Communications |Â Â ABM Therapeutics, ABM-1310, FDA, Oncology, glioblastomaÂ
ABM Therapeutics has announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ABM-1310. The drug is a novel small molecule BRAF inhibitor for the treatment of patients with glioblastoma (GBM) bearing BRAF V600 mutation.
GBM is a hard-to-treat and highly aggressive form of brain tumour with a resistance to a plethora of complex treatment. Taking routes of conventional therapies such as radiation, surgical resection and chemotherapy are suboptimal in treating the tumour. The lack of effective treatments currently on the market means that this drug receiving ODD could be a turning point for GBM treatment.
The drug is orally administered and has a high BRAF-mutation selectivity, high water solubility and high blood-brain barrier permeability, and is currently in phase 1 studies in both the US and China. Interim results from the phase 1 study were shared in June 2023 at the American Society of Clinical Oncology (ASCO) Annual Meeting. The drug currently has a good safety profile in patients with GBM and shows promising anticancer activity.
According to the company’s press release: “ABM is dedicated to the development of novel medicines to provide patients with more effective treatment options. The FDA-granted ODD marks another important milestone for the company. ABM is highly encouraged and will continue its endeavors in developing more innovative drugs, and bringing new hope and more choices to patients with cancers.”
Betsy Goodfellow
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