FDA has granted Fast Track designation (FTD) to Telix Pharmaceuticals limited New Drug Application (NDA) for TLX101-CDx (Pixclara®), for treating adult and pediatric patients with brain cancer.
Pixclara® has also received Orphan Drug designation from the FDA, offering hope to patients with brain cancer.
Telix’s NDA submission marked a significant step towards addressing the unmet medical need for an FDA-approved targeted amino acid PET agent for brain cancer imaging in the U.S.
Kevin Richardson, CEO of Telix Precision Medicine, acknowledged the significant milestone achieved with the company’s recent NDA filing for Pixclara®1 with the FDA.
Richardson emphasized the importance of this achievement in bringing Telix closer to offering an improved neuro-oncology imaging option for brain cancer patients in the U.S.
Conventional imaging techniques often fail to effectively characterize recurrent disease, leading to delays in critical treatment decisions for glioma patients.
Source: Telix Submits NDA for TLX101-CDx (Pixclara®) Brain Cancer Imaging Agent
https://www.prnewswire.com/news-releases/telix-submits-nda-for-tlx101-cdx-pixclara-brain-cancer-imaging-agent-302232277.html
