Health · Medical Research · 1 hr ago
Radiotherapies forecast to grow as Radiopharm agrees on trial plan with FDA
Telix says radiotherapy treatments could expand rapidly over the next decade, as targeted radioactive agents are used to treat tumours.
A market report cited by Telix forecasts the global nuclear medicine market will grow from US$11 billion in 2024 to US$41 billion in 2034.
Radiotherapy is forecast to grow faster than diagnostic imaging, with its market value projected to rise from US$3 billion to US$27 billion over 10 years.
Telix sells diagnostic products and is developing treatments for prostate, brain and kidney cancers; its merger with Germany’s ITM also brings access to key medical isotopes.
Radiopharm and the FDA agreed on a proposed Phase III trial plan for RAD-101, a PET imaging drug intended to help assess brain metastases in people with solid tumours.
The planned trial aims to enrol about 280 patients whose brain metastases remain uncertain after radiotherapy, and will test the drug’s ability to identify them.
The trial’s next step is to test RAD-101 in patients, though no start date is given.
Radiopharm Theranostics says it has agreed with the US Food and Drug Administration on the design of a proposed pivotal phase III trial of its RAD-101 imaging agent.
The trial is planned to enrol around 280 patients with indeterminate brain metastases after previous radiotherapy.
It aims to show sensitivity and specificity above a pre-specified performance threshold.
The development comes as the global radiotherapy market is forecast to grow rapidly over the next decade.
An earlier phase II study found 93% concordance between MRI and PET imaging in a patient population with suspected recurrence.
- Who
- Radiopharm Theranostics and the US Food and Drug Administration.
- What
- They agreed on the design of a proposed pivotal phase III trial of RAD-101.
- When
- Not stated.
- Where
- The trial is described as multicentre; specific locations are not stated.
- Why
- The study aims to assess RAD-101’s ability to image brain metastases and demonstrate sensitivity and specificity above a pre-specified threshold.
This story does not have two clearly opposing sides.
Radiopharm reported 93% concordance between MRI and PET imaging in a patient population with suspected recurrence.
Radiopharm said it and the FDA had agreed on the shape of the proposed phase III trial.
- Trial agent
- RAD-101, labelled with Fluorine-18
- Planned enrolment
- Around 280 patients
- Trial phase
- Pivotal phase III
- Earlier study result
- 93% concordance between MRI and PET imaging
- Radiotherapy market forecast
- US$3 billion to US$27 billion over 10 years, at a 26% compound annual growth rate
What people are saying
Accurately distinguishing recurrent tumor from treatment-related necrosis is one of the most important challenges physicians face when managing patients with brain metastases