Drugs

Telix Resubmits NDA for Brain Cancer Imaging Agent Pixclara

Telix Pharmaceuticals has resubmitted an NDA seeking approval of its investigational PET imaging agent Pixclara (TLX101-Px, also known as 18F-FET) for evaluating recurrent or progressive glioma. The company says the resubmission includes additional data and statistical analyses requested by the agency after it issued a complete response letter on the original filing 4/2025. Telix notes that the updated submission incorporates the new analyses alongside the primary dataset from the initial application.

Pixclara is being developed as a positron emission tomography imaging agent designed to help clinicians distinguish tumor recurrence or progression from treatment-related changes in patients with glioma, including both adults and children. Accurate differentiation between tumor growth and therapy-related effects is a major challenge in post-treatment brain cancer management.

According to Telix, the candidate has received both Orphan Drug Designation and Fast Track Designation from the FDA because of its potential to address an unmet medical need. The company noted that although PET imaging with the tracer 18F-FET is already included in international clinical practice guidelines for glioma imaging, there is currently no FDA-approved targeted amino acid PET imaging agent for brain cancer available commercially in the United States.

Pixclara targets amino acid transport proteins known as LAT1 and LAT2, which are commonly expressed in glioma cells, according to the company. The imaging agent may also serve as a potential companion diagnostic for Telix’s investigational therapeutic candidate TLX101-Tx, a LAT1-targeted radiopharmaceutical therapy currently being studied in the IPAX-BrIGHT trial for glioblastoma.

Gliomas are the most common tumors originating in the central nervous system and account for roughly 30% of all brain and central nervous system tumors and about 80% of malignant brain tumors, it says. The most aggressive subtype, glioblastoma, is diagnosed in about 22,000 patients in the U.S. each year.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome