FDA Approval Sought for Use of TLX007-CDx in PSMA PET Imaging of Prostate Cancer

A new drug application seeking the approval of TLX007-CDx for use in the preparation of prostate-specific membrane antigen (PSMA) PET imaging of prostate cancer has been submitted to the FDA, according to an announcement from Telix Pharmaceuticals.¹

TLX007-CDx is a new and proprietary cold kit designed to enable the use of a PSMA imaging product with an extended distribution profile compared with currently approved ⁶⁸Ga imaging agents. TLX007-CDx is intended to allow for more flexible production of 68Ga, which could expand the availability, distribution, and scheduling flexibility of PSMA PET imaging.

“Even in some of the most populous states [in the United States], access to PSMA PET imaging can be highly variable. Patients in rural areas of the country often bear the extra burden of long-distance travel, extended time off work, and increased out of pocket costs to access medical services,” Mike Crosby, founder and chief executive officer of Veterans Prostate Cancer Awareness, stated in a news release. “All of these factors contribute to ‘financial toxicity’ as well as challenges in accessing proper care commonly associated with cancer treatment. If approved by the FDA, [TLX007-CDx] will have a significant impact on [patients with] prostate cancer, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care and increasing the probability of patients’ survival.”

PSMA PET imaging has represented an advancement compared with prior conventional imaging methods, such as bone scans and CT scans, for use after initial diagnosis and biochemical recurrence of prostate cancer. Although PSMA PET imaging agents are approved for use in the United States, underserved patient populations are limited in their ability to access this modality. According to Telix Pharmaceuticals, only a small proportion of the 3.4 million patients with prostate cancer in the United States have undergone PSMA PET imaging.

Previously, in December 2021, Telix Pharmaceuticals received approval from the FDA for the imaging product TLX591-CDx (Illuccix) for use as a radioactive diagnostic agent for PET of PSMA-positive lesions in patients with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, as well as in those with suspected recurrence based on elevated serum prostate-specific antigen level.²

In March 2023, the FDA expanded the indication for Illuccix to include use in the selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan (Pluvicto; formerly ¹⁷⁷Lu-PSMA-617) is indicated.³

Illuccix has also been approved for Australian Therapeutic Goods Administration and Health Canada for use as a diagnostic PSMA PET imaging agent for patients with prostate cancer. Notably, no other Telix Pharmaceuticals products, including TLX007-CDx, are currently approved for use by any global regulatory agency.

“The scheduling flexibility and accessibility, along with the excellent clinical performance of 68Ga-based PSMA PET imaging, has enabled Telix to drive rapid geographic expansion of PSMA-PET imaging with our first product Illuccix,” Christian Behrenbruch, PhD, managing director and group chief executive officer of Telix Pharmaceuticals, added in a news release.1 “A core value of our company is the commitment to improving access to medicine and delivering clinical utility that will benefit patients, very much reflected in the development of this exciting new product. We believe this is particularly important as demand for PSMA PET imaging is forecast to grow significantly over the coming decade.”

References

1. Telix submits NDA for new prostate cancer imaging agent. News release. Telix Pharmaceuticals. May 27, 2024. Accessed May 28, 2024. https://telixpharma.com/news-views/telix-submits-nda-for-new-prostate-cancer-imaging-agent/
2. FDA approves Telix’s prostate cancer imaging product, Illuccix. News release. Telix Pharmaceuticals. December 20, 2021. Accessed May 28, 2024. https://telixpharma.com/news-views/fda-approves-telixs-prostate-cancer-imaging-product-illuccix/
3. FDA approves expanded indication for Telix’s Illuccix to include patient selection for PSMA-directed radioligand therapy. News release. Telix Pharmaceuticals. March 16, 2023. Accessed May 28, 2024. https://telixpharma.com/news-views/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy/