27 August 2024

TGA approves the first targeted nuclear medicine for men with prostate cancer

  • Pluvicto® (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) - the first radioligand therapy (RLT) TGA registered for eligible Australians with metastatic castration-resistant prostate cancer (mCRPC).1
  • RLT is a form of precision medicine that can treat disease with limited unwanted effects on nearby healthy cells.2,3
  • mCRPC is an advanced form of prostate cancer, often fatal, and currently there are very few treatment options available.4

The Novartis radioligand therapy Pluvicto® has become the first TGA registered RLT in Australia for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC).1

The Australian registration of Pluvicto® is based on the results of the international Phase III VISION study, published in the New England Journal of Medicine (NEJM).4 

Pluvicto® identifies cancerous cells in the body and releases medical isotopes that target and can kill those cancer cells, leaving healthy cells largely unaffected.1,4

“The TGA registration of Pluvicto® is an important moment for Australians impacted by prostate cancer, giving men and families confidence that they will have options for treatment against the most deadly forms of the disease. We commend the TGA for its role in this process and now hope to see Pluvicto®made available for patients around Australia, with the support of Federal and state governments,” said Anne Savage, CEO Prostate Cancer Foundation of Australia.

Professor Louise Emmett, Director of Theranostics and Nuclear Medicine at St Vincent’s Sydney and an investigator in the ongoing international clinical development program for Pluvicto® said “RLT has the potential to change the way we treat various types of cancers and, most importantly, outcomes for patients.”

With prostate cancer, cells develop a prostate-specific membrane antigen (PSMA) on their surface.4 Doctors will be able to directly identify this antigen and select eligible patients for the therapy, and then treat specific cancer cells with Pluvicto®.1

“The TGA registration of Pluvicto® is not just a step forward in the evolution of precision medicine but hope for eligible prostate cancer patients, who otherwise have limited treatment options. Robust clinical evidence from the VISION trial demonstrates the value of Pluvicto® in suitable men with advanced prostate cancer, improving both quality of life and survival,” said Professor Michael Hofman, a Nuclear Medicine Physician, Director of the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) at Melbourne's Peter MacCallum Cancer Centre.

Prostate cancer is the most diagnosed cancer both in Australian men and across the Australian population overall, with an estimated 25,500 cases diagnosed and more than 3,700 deaths nationally in 2023 alone.5 Per day, this equates to 70 patients diagnosed with the disease and 10 deaths.5 Currently, there are around 250,000 men living with prostate cancer in Australia, and the number is expected to reach 372,000 by 2040.6

mCRPC is an advanced form of the disease where the tumour has spread to other areas in the body and for which there are currently a very few treatment options available, as it is resistant to hormone treatment.4 The disease remains fatal despite recent advances and those living with it have approximately a 3 in 10 chance of surviving 5 years4,7.

“The TGA registration of Pluvicto® is an important moment for Australians impacted by prostate cancer, giving men and families confidence that they will have options for treatment against the most deadly forms of the disease. We commend the TGA for its role in this process and now hope to see Pluvicto®made available for patients around Australia, with the support of Federal and state governments”, said Anne Savage, CEO Prostate Cancer Foundation of Australia.

Matt Zeller, Country President, Novartis Australia and New Zealand welcomed the TGA registration: “Novartis is committed to bringing cutting edge science, research, and technology together to develop innovative medicines and ensure they make an impact for patients. The TGA registration of Pluvicto® is an important step in bringing the first TGA registered RLT manufactured at GMP (Good Manufacturing Practice) certified facilities to patients in Australia. We will continue to work together with all public, private, government stakeholders across the ecosystem to navigate and evolve the regulations and procedures for this new technology to enable consistent and equitable access for patients moving forward.”

PBS Information: Pluvicto® is not listed on the PBS.

Pluvicto® Consumer Medical Information:
For a copy of the Consumer Medicine Information, please ask your healthcare professional or visit:https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-CMI-02232-1&d=202407291723101011

References:

  1. Pluvicto Consumer Product Information. Available at:  https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2024-CMI-02232-1&d=20240729172310101 . Accessed in July 2024.
  2. Aboagye EO, Barwick TD, Haberkorn U. Radiotheranostics in oncology: Making precision medicine possible. CA Cancer J Clin. 2023;73(3):255-274. doi:10.3322/caac.2176. Available at: Radiotheranostics in oncology: Making precision medicine possible - Aboagye - 2023 - CA: A Cancer Journal for Clinicians - Wiley Online Library . Accessed in July 2024.
  3. Duan H, Iagaru A, Aparici CM. Radiotheranostics - Precision Medicine in Nuclear Medicine and Molecular Imaging. Nanotheranostics. 2022;6(1):103-117. doi:10.7150/ntno.64141. Available at: Radiotheranostics - Precision Medicine in Nuclear Medicine and Molecular Imaging - PubMed (nih.gov) . Accessed in July 2024.
  4. Ibid. 6Sartor, O et al. Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2021;385(12),1091–1103. Available at: https://doi.org/10.1056/NEJMoa2107322 . Accessed in July 2024.
  5. AIHW 2023, Cancer data in Australia. Available at:  www.aihw.gov.au/reports/cancer/cancer-data-in-australia/contents/about. Accessed in July 2024.
  6. Prostate cancer in Australia – what do the numbers tell us? Prostate Cancer Foundation Australia (PCFA). Available at: Prostate cancer in Australia – what do the numbers tell us? | PCFA . Accessed in July 2024.
  7. Eric Powers, Georgia Sofia Karachaliou, Chester Kao, Michael R. Harrison, Christopher J. Hoimes, Daniel J. George, Andrew J. Armstrong & Tian Zhang, Journal of Hematology & Oncology volume 13, Article number: 144 (2020). Novel therapies are changing treatment paradigms in metastatic prostate cancer. Novel therapies are changing treatment paradigms in metastatic prostate cancer | Journal of Hematology & Oncology | Full Text (biomedcentral.com)Accessed in July 2024.

ENDS 

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