Telix submits NDA for new prostate cancer imaging kit

Telix Pharmaceuticals has submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) for a new prostate-specific membrane antigen (PSMA)-PET cold kit for prostate cancer imaging.

Called TLX007-CDx, the kit enables more flexible production, including with gallium-68 (Ga-68) sourced from both newer high-activity generators and cyclotrons powered by ARTMS’ Quantm irradiation system and GE HealthCare’s FASTlab solid and liquid target production system.

The new kit is expected to further expand the availability, distribution, and scheduling flexibility of PSMA-PET imaging, Telix said.

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