Telix submits US drug application for prostate cancer imaging kit
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The news: Telix Pharmaceuticals has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) for a proprietary cold kit for the preparation of imaging for prostate cancer.
The context: Telix said the kit’s innovative properties are designed to facilitate more flexible production, including with currently approved gallium-68 (68Ga) PSMA-PET imaging agents. This will further expand the availability, distribution and scheduling flexibility of PSMA-PET imaging.
Telix said PSMA-PET imaging represents a major advancement in prostate cancer management and in the US has replaced conventional imaging methods including bone scan and CT scan as the standard of care after initial diagnosis and biochemical recurrence.
Despite this major medical advancement, only a relatively small fraction of the 3.4 million men living with prostate cancer in America have undergone a PSMA-PET imaging scan, the company said.
Last month, the company secured a fast track designation for an investigational brain tumour imaging product from the FDA.
The source: ASX announcement
