Melbourne (Australia) and Indianapolis, IN (USA) – 16th December 2020. Telix has filed a New Drug Submission (NDS) with Health Canada for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11).
Telix is pleased to announce the filing of a New Drug Submission (NDS) with Health Canada for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate Specific Membrane Antigen (PSMA) for the imaging of prostate cancer with Positron Emission Tomography (PET).
Consistent with other jurisdictions, Telix is seeking a product approval in Canada for TLX591-CDx for the following indications:
Staging and re-staging of intermediate and high-risk prostate cancer
Localizing PSMA positive tissue in recurrent prostate cancer
Telix Americas President, Dr Bernard Lambert stated, “We are pleased to have achieved this important milestone with the submission of the first commercial NDS for PSMA imaging in Canada. Subject to Health Canada approval, we look forward to bringing this product to market to serve the needs of Canadian men living with prostate cancer.”