Telix Pharmaceuticals Updates on Precision Medicine Portfolio
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Illuccix China Phase 3 Registration Study
The company announced positive top-line results from its Phase 3 registration study of TLX591-CDx, a PET imaging agent for prostate cancer, conducted in Chinese patients. This study met its primary endpoint, demonstrating a patient-level positive predictive value (PPV) of 94.8% for detecting tumors in patients with biochemical recurrence (BCR) of prostate cancer after prior treatments such as radical prostatectomy or radiation therapy. The trial, which involved 140 patients, confirmed that the clinical performance of TLX591-CDx in Chinese patients is comparable to results observed in other regions. The region-level PPV was notably high, reaching 100% in the prostate bed and extra-pelvic soft tissue, while it was 94.7% in pelvic regions outside the prostate bed and 87.0% in bone metastases. Moreover, the imaging prompted a change in treatment plans for 67.2% of patients, indicating a significant impact on clinical decision-making. Dr David N. Cade, Telix's Group Chief Medical Officer, emphasized the importance of these results, stating that they would support a New Drug Application (NDA) submission for Illuccix in China, a market with over 134,000 new prostate cancer diagnoses in 2022.FDA Resubmission Update: TLX101-CDx
In the United States, Telix is finalizing its NDA resubmission for TLX101-CDx (Pixclara®), a PET imaging candidate for glioma. Following a productive Type A meeting with the FDA, the company is revising its statistical analysis plan and providing additional clinical data to support the resubmission. The approved Expanded Access Program for TLX101-CDx remains active, reflecting Telix's commitment to patient access while the resubmission process is underway.FDA Resubmission Update: TLX250-CDx
Telix also reported on TLX250-CDx (Zircaix®), a PET imaging candidate for clear cell renal cell carcinoma (ccRCC). After receiving a Complete Response Letter (CRL) from the FDA, the company held a Type A meeting to discuss the identified deficiencies related to the product's chemistry, manufacturing, and controls (CMC). Telix believes it has aligned with the FDA on remediation strategies and has been granted an additional meeting in January to review its data plan for establishing comparability between the clinical trial product and the commercial manufacturing process. The company plans to provide further updates following the receipt of official meeting minutes from the FDA.Strategic Implications
The positive results from the Illuccix study in China are expected to enhance the standardization of PSMA-PET imaging in BCR pathways, potentially increasing scheduling volumes and operational readiness for generator-based 68Ga labeling. In the US, the outcomes of the NDA resubmissions for TLX101-CDx and TLX250-CDx will be critical for Telix's credibility with regulators and could influence the future of its diagnostics portfolio. As Telix navigates these developments, the company is also aware of competitive pressures from other imaging agents and local alternatives in China, which could impact pricing and market dynamics. In conclusion, Telix Pharmaceuticals is making significant strides in its precision medicine portfolio, with promising data from its studies and ongoing regulatory engagements that could lead to enhanced treatment options for patients with prostate cancer and glioma in the near future.Related articles
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