Brain tumour therapy company GT Medical Technologies has received US Food and Drug Administration (FDA) clearance for an expanded indication of its GammaTile therapy.
Previously reserved for patients with recurrent brain tumours, patients with newly diagnosed malignant brain tumours are now eligible to receive its surgically targeted radiation therapy (STaRT).
The device, which features a bioresorbable collagen tile with embedded radiation seeds, is designed specifically for use in the brain and offers advantages for patients undergoing surgery for brain tumours. GammaTile is designed to be implanted in the head after surgery to delay regrowth by immediately delivering radiation to the site from which the tumour was removed.
This means patients are able to target residual tumour cells immediately, rather than wait several weeks for surgical wounds to heal before beginning treatment. There is no need for them to visit a clinic to undergo a radiotherapy session, as the device delivering the therapy is already implanted.
GammaTile radiation therapy became available to patients with recurrent brain tumours in January 2019, and is the most recent treatment cleared or approved by the FDA for brain tumours.
GT Medical Technologies president and CEO Matthew Likens said: “We are pleased to offer GammaTile Therapy to patients who are newly diagnosed with malignant brain tumours, in addition to patients with recurrent brain tumours.
“This is a significant step forward that expands our ability to improve the lives of patients with brain tumours. Patients receiving GammaTile Therapy immediately after the removal of a brain tumour will have the peace of mind that they are accelerating their radiation treatment and targeting residual tumour cells where treatment is most needed to help prevent recurrence.”
In a clinical study, data from which was presented at the 2019 Society of Neuro-Oncology Annual Meeting, local control of tumour growth was achieved in approximately 90% of patients who were implanted with a GammaTile after gross total resection.
University of Minnesota Medical School Department of Neurosurgery head Dr Clark Chen said: “GammaTile Therapy is an important addition to the armamentarium of treatments available against brain cancer. It has the potential to improve the quality of life as well as clinical outcome. I am encouraged by the FDA’s decision to expand the indications for this therapy.”