FDA grants Telix breakthrough therapy designation for renal cancer imaging product

Telix Pharmaceuticals ASX TLX FDA Breakthrough Therapy Designation Renal Cancer imaging product
Telix’s TLX250-CDx product is currently being prepared for Phase 3 trials.

Clinical-stage biopharmaceutical company Telix Pharmaceuticals (ASX: TLX) has received confirmation from the FDA that its kidney cancer imaging product TLX250-CDx had been granted breakthrough therapy (BT) designation.

The company claims to “deliver on the promise of nuclear medicine”, a field of medicine that has historically lacked clinical momentum commitment to late-stage product development.

More specifically, Telix is currently progressing a drug pipeline focused on unmet needs in prostate, kidney, and brain cancer.

Under BT status, TLX250-CDx, also known as “89Zrgirentuximab” will be closely developed by Telix and the FDA with the ultimate intention of diagnosing “indeterminate renal masses” that have been identified on CT or MRI imaging.

TLX250-CDx is being developed to determine whether such renal masses are either clear cell renal cell cancer (ccRCC) or non-ccRCC, using positron emission tomography (PET) imaging.

According to Telix, the FDA’s BT designation offers a series of “significant benefits”, including eligibility for fast track designation, a greater degree of collaboration with the US regulator and the opportunity to submit what’s known as a “rolling biological licence application” for TLX250-CDx, whereby the application is submitted in separate modules to streamline the FDA review process for approval.

“The granting of Breakthrough designation by the FDA for our kidney cancer imaging product provides Telix with the opportunity to interact closely with the FDA to expedite the registration process of TLX250-CDx, a particularly important consideration given the current Phase III development status of the asset,” said Telix Pharmaceuticals chief executive officer Dr Christian Behrenbruch.

“There is a significant unmet medical need to improve diagnosis and staging of clear cell renal cell carcinoma (ccRCC), which is the most common and aggressive form of kidney cancer. It’s encouraging that the Agency [FDA] recognises this,” he added.

ZIRCON Phase 3 trial

In mid-June, Telix announced that its ZIRCON phase 3 trial of TLX250-CDx had recommenced patient recruitment in Europe, following a halt to all activity due to COVID-19.

Telix said that patient recruitment for the trial had restarted in France with the dosing of two patients with TLX250-CDx at Centre Hospitalier Universitaire de Nantes in Nantes, France.

Clinical sites in Belgium and the Netherlands have also been reactivated, with patient recruitment fully back up to speed by the end of June 2020.

Zirconium imaging in renal cancer oncology (ZIRCON) is an international multi-centre Phase 3 study at 33 sites in Europe, Australia, Turkey, Canada and the US.

The imaging trial is being carried out in 250 renal cancer patients undergoing kidney surgery, to determine the sensitivity and specificity of TLX250-CDx PET imaging to detect clear cell renal cell cancer (ccRCC) in comparison with histologic “standard of truth” determined from surgical resection specimens.

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