FET F-18

October 2024 saw significant FDA actions in oncology, including priority reviews for T-DXd in HER2-low/ultra-low breast cancer, acalabrutinib for frontline mantle cell lymphoma, and approvals for nivolumab plus chemotherapy in operable NSCLC, Cologuard Plus for CRC screening, and zolbetuximab for HER2-negative gastric cancer. Other notable actions included fast track designations, orphan drug designations, and expanded approvals for various cancer treatments.

The FDA granted priority review to TLX101-CDx for PET imaging in progressive or recurrent glioma, with a decision set for April 26, 2025. TLX101-CDx targets LAT and LAT2 proteins, potentially serving as a companion diagnostic for TLX101, an anti-glioblastoma therapy. Clinical trials IPAX-2 and IPAX-Linz are assessing TLX101's safety and efficacy.

FDA accepts NDA for glioma imaging agent 18F-floretyrosine (18F-FET; TLX101-CDx; Pixclara) with priority review, decision expected by April 26, 2025. 18F-FET aims to improve brain cancer imaging in the US, addressing limitations of MRI. It may also serve as a companion diagnostic for TLX101-Tx (131I-iodofalan; 131I-IPA), currently in trials for glioblastoma.

Telix submits NDA to FDA for TLX101-CDx (Pixclara™), a PET agent for brain cancer imaging, granted Orphan Drug and Fast Track designation. Pixclara™ aims to improve glioma diagnosis and management, currently not FDA-approved in the U.S.