Telix Pharmaceuticals (ASX:TLX), a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or 'molecularly-targeted radiation' (MTR), has announced the submission to the US FDA of a Drug Master File (DMF) for a sterile kit used in the preparation of 68Ga-PSMA-11 (PSMA Kit).
According to Dr Bernard Lambert, president of Telix USA, “The filing of this DMF marks an important step towards offering a commercial PSMA prostate imaging solution for the US market, and we are the first to have achieved this accomplishment in collaboration with our partner, ANMI.
"There is considerable demand for effective prostate imaging in the United States and we already have several leading cancer hospitals preparing to use the PSMA Kit. We’d also like to acknowledge the excellent work of our colleagues at NukeMed and the team at Indiana University, who worked tirelessly over the past six months to complete the validation work.”
The company said the PSMA Kit had been validated for use with all major vendors of 68Ga generators, including Eckert & Ziegler, ITM2 and IRE ELiT3.
The PSMA Kit is expected to be commercially available by mid-2018, subject to FDA review of the manufacturing package.