The expanded approval allows GammaTile therapy to treat patients with newly diagnosed malignant brain tumours
Patients with newly diagnosed malignant tumours are now eligible to receive FDA-cleared GammaTile therapy (Credit: Business Wire)
GT Medical Technologies has secured expanded approval from the US Food and Drug Administration (FDA) for its GammaTile therapy.
The FDA-cleared surgically targeted radiation therapy (STaRT) can now be used by patients with newly diagnosed malignant brain tumours.
GammaTile therapy is claimed to be the only radiation therapy particularly developed for use in the brain. It has been made available since January 2019.
The therapy starts begins targeting residual tumour cells immediately at the time of tumour removal surgery, instead of waiting several weeks for surgical wound healing before the commencement of treatment.
GammaTile protects healthy brain tissue
GammaTile therapy will be implanted at the end of excision surgery to immediately target residual tumour cells.
It has been designed to safeguard healthy brain tissue while delivering a targeted dose to any remaining tumour cells.
Its advanced design also helps in reducing side effects generally associated with radiation therapy, including hair loss.
With the size of a postage stamp, GammaTile therapy includes a bioresorbable, conformable and 3D-collagen tile and uniform radiation source called Cesium-131. It is supplied by Isoray.
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 tumor cells where treatment is most needed to help prevent recurrence.”
Earlier this month, scientists from the UK’s Institute of Cancer Research, along with researchers and clinicians from the Royal Marsden NHS Foundation Trust, have conducted a phase II clinical trial of radiotherapy in patients with a type of bladder cancer.