FDA OKs TLX007-CDx in Prostate Cancer Treatment
TLX007-CDx is now an FDA-approved PSMA PET imaging agent in prostate cancer.
- The FDA has approved TLX007-CDx for prostate cancer.
- TLX007-CDx is a new and proprietary cold kit for the preparation of prostate-specific membrane antigen (PSMA)-PET imaging.
- The cold kit may also enable use of a PSMA imaging product with an extended distribution profile compared with currently approved gallium-68 (68Ga) PSMA-PET imaging agents, according to the company.
The FDA has granted approval to TLX007-CDx (Gozellix) for the preparation of PSMA-PET imaging for prostate cancer.1
TLX007-CDx is a cold kit designed for the preparation of PSMA-targeted PET imaging for prostate cancer. It leverages high-activity 68Ga sourced from advanced generators and cyclotrons, supported by the ARTMS QUANTM Irradiation System alongside GE’s FASTlab solid and liquid target production systems.
Prostate cancer, bladder cancer, men's health care: © Tom - stock.adobe.com
TLX007-CDx offers a PSMA imaging option with a potentially extended distribution profile compared with currently approved 68Ga-based PSMA-PET agents.
Previously in July 2024, the FDA accepted the filing of a new drug application (NDA) for TLX007-CDx.2
In December 2021, the FDA approved 68Ga-PSMA-11 (Illuccix), a kit for the preparation of gallium Ga 68 gozetotide injection in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy.3 This approval is also intended for patients with suspected recurrence based on elevated serum prostate-specific antigen.
The FDA expanded the indication of Illuccix in March 2023 to include patients with metastatic prostate cancer indicated for 177Lu 177 PSMA (Pluvicto)-directed therapy.4 68Ga-PSMA-11 is approved in Canada and Australia.
