Telix Pharmaceuticals Limited (ASX: TLX) has been granted Orphan Drug Designation (ODD) by the US Food and Drug Administration (FDA) for the positron emission tomography (PET) imaging of glioma, a type of brain tumour.
CEO Dr Christian Behrenbruch said the granting of an ODD for the company’s O-(2-[F]fluoroethyl)-L-tyrosine (F-FET) system qualifies Telix for various drug development incentives which may include FDA administered market exclusivity for seven years, waived FDA prescription drug user fees, and tax credits for R&D and clinical development costs.
Gliomas comprise a group of primary brain tumours arising from glial cells which surround and support the neurons of the brain, exhibiting an annual incidence of over 22,000 cases in the United States and representing over 80% of all malignant brain tumours.
F-FET has been widely used in clinical research settings while recently, new practice guidelines have been developed for the imaging of gliomas using PET with radiolabeled amino acids, of which F-FET is a key enabling radiopharmaceutical.
F-FET targets the amino acid transport system L (LAT) and is therefore highly suitable for use as a ‘companion diagnostic’ to TLX101, Telix’s therapeutic drug candidate for treating glioblastoma, a highly aggressive form of glioma.
F-FET is used to select patients and track disease response in Telix’s IPAX-1 Phase I/II clinical trial (ClinicalTrials.gov Identifier: NCT03849105), which is currently recruiting patients in Europe and Australia.
PET imaging of the brain is increasingly used to supplement conventional imaging with MRI, which for many years has been the primary clinical imaging modality in patients with glioma at all stages of disease,” Dr Behrenbruch said.
“The granting of an Orphan Drug Designation by the FDA for F-FET provides Telix with the option to develop this valuable PET imaging agent commercially, to ensure it is available to patients with glioma across the disease spectrum. F-FET’s relevance as a patient selection and therapeutic monitoring tool for TLX101 is particularly beneficial to the company.”