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A Biologics License Application has been submitted to the FDA for treatment with the kidney cancer imaging PET drug product, Zircaix®.
Telix Pharmaceuticals has submitted a BLA to the FDA for the kidney cancer imaging PET drug product, Zircaix.
Telix Pharmaceuticals has submitted a Biologics License Application (BLA) to the Food and Drug Administration (FDA) for the kidney cancer imaging PET drug product, Zircaix (TLX250-CDx; 89Zr- girentuximab), according to a press release from the company.
“We are pleased to be progressing the BLA for [Zircaix], which has been granted Breakthrough designation, and may therefore be eligible for priority review. Telix continues to target a full U.S. commercial launch in 2025 addressing a major unmet medical need for patients with suspected clear cell renal cell carcinoma [ccRCC],” Kevin Richardson, chief executive officer of Precision Medicine at Telix, stated in the press release.
Biologics License Application (BLA): a request to the FDA for permission to sell a biologic product across state lines.
Nephrectomy: a surgical procedure to remove one or both kidneys.
Prescription Drug User Fee Act (PDUFA): a law that allows the FDA to collect fees from companies that submit certain human drug applications for review.
The Food and Drug Administration (FDA): a federal agency that protects the public's health.
ccRCC is classified as the most common and aggressive form of kidney cancer, and if approved, the investigational drug product will serve as a non-invasive way to diagnosis and characterize patients. Furthermore, if approved, Zircaix will also be the first and only targeted PET agent specifically for kidney cancer to be commercially available in the U.S.
The agent, which is under development, is currently being investigated in the phase 3 ZIRCON trial. The confirmatory, prospective, open-label, multi-center study evaluated the sensitivity and specificity of Zircaix imaging and its ability to non-invasively detect ccRCC in adult patients with indeterminate renal masses, scheduled for partial or total nephrectomy.
Participants were given administration of 89Zr-TLX250 and imaging was then conducted both pre- and post-administration. The patients’ nephrectomies were then performed at institutional discretion any time following the PET imaging visit but was not done any later than 90 days post-administration of 89Zr-TLX250. Image data analysis was then performed, in which unexpected evidence for disseminated disease is observed.
Patients eligible for enrollment onto the trial consisted of anyone 18 years of age or older with imaging evidence of a single indeterminate renal mass of 7 centimeters or smaller in the largest diameter and who were scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration, as well as sufficient life expectancy to justify nephrectomy. Moreover, patients were only included in France, and female patients of childbearing potential must not have been pregnant.
Exclusion criteria consisted of a bioptic procedure planned; renal mass known to be a metastasis of another primary tumor; active renal malignancy requiring therapy during the time frame of the study; chemotherapy, radiotherapy or immunotherapy within a four-week period prior to planned investigative treatment administration; and serious non-malignant disease that may interfere with the objectives of the study.
In total, 300 patients were evaluated, of which 284 were evaluable for enrollment. These patients met all primary and secondary end points, and showed an 86% sensitivity, an 87% specificity and a 93% positive-predictive value for ccRCC across three independent radiology readers.
“Telix believes [that these data] demonstrated the ability of [Zircaix] to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing and characterizing ccRCC. Confidence intervals exceeded expectations amongst all three readers, showing evidence of high accuracy and consistency of interpretation,” the company cited in the press release.
Notably, the company shared that following the 60-day administrative review of the application by the regulatory agency, the FDA is expected to advise the Prescription Drug User Fee Act (PDUFA) goal date.
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