- Clinical-stage biopharmaceutical company Telix Pharmaceuticals’ (TLX) new drug application for its prostate cancer imaging product has been accepted by the U.S. Food and Drug Administration
- The technology, TLX591-CDx, targets a protein found on the surface of prostate cancer cells, dubbed prostate-specific membrane antigen (PSMA)
- In its submission, Telix also requested a priority review — the outcome of which will be announced in around two weeks
- This is a significant milestone, as it marks the first commercial new drug application for PSMA imaging in the United States
- On the market this morning, Telix is up 12.3 per cent and trading at $3.19 per share
Telix Pharmaceuticals’ (TLX) new drug application for its prostate cancer imaging product has been accepted for filing by the U.S. Food and Drug Administration (FDA).
The technology, TLX591-CDx, is a preparation kit for Ga-PSMA-11, which targets prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. It uses the imaging technique known as positron emission tomography (PET).
The company submitted the technology to the FDA in September and requested a priority review, the outcome of which is expected around December 10. The submission included clinical data from over 600 patients.
Prostate cancer is the second most common cancer in men, following skin cancer. In 2018, 1.3 million men were diagnosed with the cancer for the first time.
Chief Medical Officer Dr Colin Hayward believes this type of technology is quickly becoming the standard of care for prostate cancer imaging.
“PSMA imaging is already included in the leading clinical practice guidelines in the United States and Europe, based on evidence that definitively demonstrates superiority over conventional imaging. This is highly supportive of rapid adoption of Telix’s product upon approval,” he said.
The acceptance is a significant milestone, as it marks the first commercial new drug application for PSMA imaging in the United States.
CEO Dr Christian Behrenbruch says this represents a major step towards Telix’s goal to provide this product to patients in the United States.
“We now look forward to working with the FDA to bring TLX591-CDx to American patients living with prostate cancer as expeditiously as possible,” he concluded.
On the market this morning, Telix is up 12.3 per cent and trading at $3.19 per share at 11:39 am AEDT.