ASX News

Telix Pharmaceuticals Files New Drug Submission with Health Canada for Prostate Cancer Imaging Product

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.”

To learn more about this announcement including ASX release, please click here.

More Articles

ASX News

First U.S. Patients Dosed in Phase III ZIRCON Trial of Renal Cancer Imaging Product

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 25th January 2021. Telix Pharmaceuticals announces the first U.S. patients have been dosed...

Corporate Spotlight

Telix Pharmaceuticals Appoints Danielle Meyrick MD as CMO, Asia-Pacific

22nd January 2021 – Corporate Spotlight | Telix Pharmaceuticals welcomes Dr Danielle Meyrick as Chief Medical Officer, Asia Pacific

Corporate Spotlight

ARTMS and Telix Pharmaceuticals Announce Successful Production of 68Ga PSMA-11 with Cyclotron Produced 68Ga from a Solid Target

Burnaby, Canada and Indianapolis, USA, January 12, 2021 – ARTMS Inc. and Telix announce successful production of Telix’s prostate cancer...

ASX News

Telix Pharmaceuticals Files New Drug Submission with Health Canada for Prostate Cancer Imaging Product

Melbourne (Australia) and Indianapolis, IN (USA) – 16th December 2020. Telix has filed a New Drug Submission (NDS) with Health Canada...

ASX News

Telix Pharmaceuticals and Mauna Kea Technologies Launch Urologic Oncology Alliance

Melbourne (Australia) – 16th December 2020. Telix Pharmaceuticals announces collaboration with Mauna Kea Technologies to develop advanced image-guided surgical technologies in the field...

ASX News

Telix and Kanazawa University Commence Japanese Clinical Study for Prostate Cancer Imaging

Melbourne (Australia) – 14th December 2020. Telix announces its subsidiary, Telix Pharmaceuticals Japan KK, has entered a clinical study collaboration...

ASX News

Telix Completes IP Agreement with the University of Southampton (UK) Granting Exclusive Access to TRALA Clinical Trial Data

Melbourne (Australia) – 14th December 2020. Telix Pharmaceuticals Limited announces today that its wholly-owned subsidiary TheraPharm GmbH has completed an...

ASX News

Telix Granted TGA Priority Review for Prostate Cancer Imaging

Melbourne (Australia) – 7th December 2020. Telix has been granted Priority Review status for TLX591-CDx (68Ga-PSMA-11), a radiopharmaceutical for the...

ASX News

Telix and DuChemBio Announce Korean Partnership for Advanced Prostate Cancer Imaging

Melbourne (Australia) and Seoul (South Korea) – 3rd December 2020. Telix Pharmaceuticals announces it has entered into a licensing and partnership...

ASX News

Telix Receives Approval for First-In-Human Study of Next Generation Prostate Cancer Therapy Product

Melbourne (Australia) – 2nd December 2020. Telix has been granted HREC approval and received CTN clearance by the TGA to...

ASX News

Investor Briefing – TheraPharm GmbH Acquisition

Melbourne (Australia) – 1st December 2020. Telix Pharmaceuticals Provides Investor Briefing: TheraPharm GmbH Acquisition

ASX News

Telix Pharmaceuticals Limited Acquires TheraPharm GmbH

Melbourne (Australia) and Baar (Switzerland) –  30th November 2020. Telix announces it has entered into an agreement with Scintec Diagnostics...

ASX News

Telix New Drug Application for Prostate Cancer Imaging Product Accepted by US FDA

Melbourne (Australia) and Indianapolis, IN (U.S.A.) – 24th November 2020. Telix Pharmaceuticals announces New Drug Application (NDA) for TLX591-CDx (Kit...