Telix Pharmaceuticals (Innovations) Pty Limited - Expanded Access Programs

Expanded Access Intelligence

Official Statements

Score contribution: 100 — 3 supporting sources.

Score 1003 references

Featured Reference

Policy on Offering Compassionate Use to Investigational MedicinesOpens in new window

“At Telix, a compassionate use program, or a single request for compassionate use of an investigational medicine, can only be considered if all of the following conditions are met:... If all these conditions are met, Telix will consider compassionate use requests from treating physicians subject to local/national laws and regulations.”

Policy on Offering Compassionate Use and Early or Expanded ...Source

“Telix also has ethical responsibilities for compassionate use or early/expanded access of our investigational medicines. We consider many factors when considering a request for compassionate use or early/ expanded access of an investigational medicine, such as the level of safety and efficacy supported by stringently obtained clinical data, the risk-benefit profile of the patient, the potential impact on the clinical development program, the phase of development, the experience of the requesting healthcare team with radiopharmaceuticals and probability and timing of regulatory approval.”

Clinical Trials | Telix PharmaceuticalsSource

“Telix is often contacted to provide access to our products under compassionate use. We respect the treatment journey of the patient and the independence of healthcare professionals in making their treatment decisions. Telix tries to accommodate such requests whenever it is clinically, ethically and practically feasible to do so.”

EAP Related Articles from Sponsor

Score contribution: 80 — 5 supporting sources.

Score 805 references

Featured Reference

First Patient Dosed in U.S. Expanded Access Program for TLX250-CDx, Telix’s Breakthrough Kidney Cancer Imaging Agent | Telix PharmaceuticalsOpens in new window

Telix today announces that the first patient has been dosed in a United States (U.S.) expanded access program (EAP, ClinicalTrials.gov ID: NCT06090331) for TLX250-CDx (89Zr-DFO-girentuximab). TLX250-CDx is the Company’s first-in-class, non-invasive investigational positron emission tomography (PET) imaging agent in clear cell renal cell carcinoma (ccRCC).

Expanded Access Program Opens in the U.S. for TLX101-CDx, Telix’s Investigational Glioma (Brain Cancer) Imaging Agent | Telix PharmaceuticalsSource

Telix today announces the opening of an expanded access program (EAP) in the United States (U.S.) for TLX101-CDx (Pixclara®[1], 18F-floretyrosine or 18F-FET) an investigational positron emission tomography (PET) agent for imaging progressive or recurrent glioma, following U.S. Food and Drug Administration (FDA) agreement to proceed.

First Patient Dosed in Austrian Named Patient (Early Access) Program for TLX250-CDx, Telix’s Kidney Cancer Imaging Agent | Telix PharmaceuticalsSource

Telix today announces that the first patient has been dosed in a named patient program in Austria for TLX250-CDx... Through this named patient program (‘Heilversuch’), physicians may seek individual patient access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC... Frédéric Fantino, Telix Medical Director for the Europe, Middle East and Africa (EMEA) region added, “We are pleased to provide continued access to TLX250-CDx in Austria, in doing so broadening the European footprint for Telix’s global expanded access program.

First Patient Dosed in Italian Named Patient (Early Access) Program for TLX250-CDx, Telix’s Kidney Cancer Imaging Agent | Telix PharmaceuticalsSource

Telix today announces that the first patient has been dosed in its named patient program in Italy for TLX250-CDx... Through this program (‘accesso allargato’), physicians may seek individual patient access to TLX250-CDx for use in PET characterisation of renal masses as ccRCC... Italy becomes the third active country in Telix’s global expanded access program, where first patients were dosed in the Netherlands and the United States (U.S.) in December 2023.

First Patient Dosed in European Named Patient (Early Access) Program for TLX250-CDx, Telix’s Kidney Cancer Imaging Agent | Telix PharmaceuticalsSource

Telix today announces that the first patient has been dosed in a named patient (early access) program in the Netherlands for its investigational positron emission tomography (PET) imaging agent TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer.

Active EAPs on ClinicalTrials.gov

Score contribution: 60 — 2 supporting sources.

Score 602 references

Featured Reference

89Zr-DFO-girentuximab Expanded Access Program (EAP)Opens in new window

Conditions: Clear Cell Renal Cell Carcinoma

18F-Floretyrosine Expanded Access ProgramSource

Conditions: Glioma (Any Grade) in the Brain

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