Telix Pharmaceuticals’ Kidney Cancer Imaging Agent TLX250-CDx (Zircaix®2) Receives Priority Review from FDA
Melbourne, Australia and Indianapolis, February 26, 2025 – Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix), a leading global diagnostic company specializing in the development and commercialization of diagnostic and therapeutic products based on targeted radiopharmaceuticals, is thrilled to announce that the United States Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for its investigational kidney cancer PET1 imaging agent, TLX250-CDx (Zircaix®2, 89Zr-DFO-girentuximab).
FDA Grants Priority Review and Sets PDUFA Date
This significant milestone marks the commencement of the regulatory review process for TLX250-CDx, which has been granted a Priority Review designation. The Prescription Drug User Fee Act (PDUFA) target action date, or PDUFA3, has been set for 27 August 2025.
Implications for the Patients and the Medical Community
The acceptance of the BLA and the granting of a Priority Review by the FDA represent a significant step forward in the development of TLX250-CDx, which has the potential to transform the diagnosis and management of kidney cancer. If approved, TLX250-CDx will offer a more accurate and earlier diagnosis, enabling better treatment decisions and improved patient outcomes.
Impact on Telix Pharmaceuticals
The positive regulatory news follows Telix’s recent successful initial public offering on the Nasdaq stock exchange and the recent acquisition of the Prostate Cancer Imaging business from Ipsen. These milestones, along with the anticipated approval of TLX250-CDx, position Telix as a key player in the diagnostic imaging market and are expected to drive significant growth for the company.
Global Implications
The acceptance of the BLA and the potential approval of TLX250-CDx in the U.S. market will set the stage for a commercial launch in 2025. The global kidney cancer diagnostic market is expected to grow at a CAGR of 7.5% from 2020 to 2027, driven by the increasing prevalence of kidney cancer, growing awareness, and the availability of advanced diagnostic technologies. The launch of TLX250-CDx is expected to significantly contribute to this market growth.
Conclusion
The acceptance of Telix Pharmaceuticals’ BLA for its investigational kidney cancer imaging agent, TLX250-CDx, by the FDA represents a significant milestone in the development of this potentially game-changing diagnostic tool. With a Priority Review and a PDUFA3 date set for 27 August 2025, the regulatory approval process is now underway. This approval could lead to earlier and more accurate diagnoses for kidney cancer patients, transforming the current diagnostic landscape and driving growth for Telix Pharmaceuticals. The global kidney cancer diagnostic market is poised for significant growth, and the anticipated approval of TLX250-CDx is expected to contribute significantly to this expansion.
- Telix Pharmaceuticals’ investigational kidney cancer imaging agent, TLX250-CDx, has been accepted for review by the FDA.
- The BLA has been granted a Priority Review, and a PDUFA3 date of 27 August 2025 has been set.
- If approved, TLX250-CDx will offer a more accurate and earlier diagnosis, enabling better treatment decisions and improved patient outcomes.
- The approval could significantly contribute to the growth of Telix Pharmaceuticals and the global kidney cancer diagnostic market.
