Novartis’ radioligand therapy nabs first regulatory approval in prostate cancer

Pharma News: Prostate cancer remains the most commonly diagnosed cancer in Australian men and across the population. Novartis Australia’s Pluvicto – formerly known as 177Lu-PSMA-617 – has achieved a historic milestone as the first radioligand therapy (RLT) registered by the Therapeutic Goods Administration (TGA) in Australia for metastatic castration-resistant prostate cancer (mCRPC).

The approval of Pluvicto follows Novartis’s strategic $2.1 billion acquisition of Endocyte in 2018, which complemented the earlier $3.9 billion purchase of Advanced Accelerator Applications.

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

The potential of Pluvicto is highlighted in the phase 3 Vision trial, where it demonstrated a 38% reduction in the risk of death compared to standard treatments alone in PSMA-positive mCRPC patients. Those receiving Pluvicto lived a median of 15.3 months, a significant improvement over the 11.3 months observed in the control group.

Professor Michael Hofman, Director of the Prostate Cancer Theranostics and Imaging Centre of Excellence (ProsTIC) at Melbourne’s Peter MacCallum Cancer Centre, emphasised the significance of this approval.

“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,” Professor Hofman stated.

More than 250,000 men in Australia are living with prostate cancer, a number projected to rise to 372,000 by 2040. Despite recent advancements, mCRPC remains a fatal condition with only a 30% chance of surviving five years.

Anne Savage, CEO of the Prostate Cancer Foundation of Australia, said “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.”

Matt Zeller, Country President of Novartis Australia and New Zealand, welcomed the approval, saying “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, and 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.”

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