In July 2023, the U.S. FDA granted Orphan Drug designation to ABM-1310, an investigational treatment option for people living with malignant gliomas such as glioblastoma. Now, reports clinical-stage biopharmaceutical company ABM Therapeutics in a recent news release, the FDA has also granted Fast Track designation to ABM-1310 for glioblastoma in people with BRAF V600E mutations.
This process helps to facilitate the development and expedite the review of therapeutic options that can fill unmet needs and treat serious, rare, and life-threatening conditions. The Fast Track designation comes alongside benefits such as increased FDA meetings, Priority Review and Accelerated Approval eligibility, and Rolling Review. Learn more about Fast Track designation here.
About ABM-1310
ABM Therapeutics describes ABM-1310 as:
a highly potent and selective BRAF inhibitor with an excellent cell permeability and brain penetration. The compound was designed to address a majority of BRAF V600E mutated cancers, which happen in about 8% of total cancers, such as colorectal cancer, melanoma drug resistance and brain metastasis, and glioma.
Current therapies, says ABM Therapeutics, fail to have promising brain penetrance. Therefore, ABM-1310 has the potential to overcome current obstacles to care and improve outcomes. This therapy is being explored in a Phase 1 clinical study for solid tumors.
What is Glioblastoma?
Also known as grade IV astrocytoma, glioblastoma is a rare and aggressive tumor that typically forms in the cerebrum. Glioblastoma is considered an extremely aggressive cancer as the tumors are capable of creating their own blood supply. This allows them to spread to other areas of the brain.
Glioblastoma is most common in older individuals (ages 60+) although it can form in younger individuals. Doctors do not know the exact cause of glioblastoma but have identified risk factors. For example, if you had radiation therapy for leukemia or a childhood brain tumor or have a condition such as Li-Fraumeni syndrome, Turcot syndrome, or Lynch syndrome, you may have a higher risk of developing this cancer. Unfortunately, glioblastoma is often difficult to treat. Doctors may leverage a blend of surgery, radiation, chemotherapy, and electric-field therapy. Still, many tumors regrow after their initial treatment or removal.
Symptoms may include:
- Severe and persistent headaches
- Muscle weakness or paralysis
- Double or blurred vision
- Nausea and vomiting
- Fatigue
- Issues with balance and coordination
- Changes in mood, behavior, or personality
- Difficulty thinking or speaking
- Seizures
