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FDA approves Novartis’ Pluvicto for prostate cancer

The treatment is the first FDA approved targeted radioligand therapy for mCRPC patients


Novartis has announced that it has received approval from the US Food and Drug Administration (FDA) for Pluvicto for the treatment of adult patients with advanced prostate cancer.

The approval is based on the results of the phase 3 VISION trial that evaluated the effectiveness and safety profile of the drug.

Patients involved in the trial who were treated with Pluvicto and standard of care had a 38% decrease in the risk of death, while a statistically significant reduction was also shown in the risk of radiographic disease progression or death compared to standard of care alone.

There were more than 1.4 million new cases and 375,000 deaths in 2020 alone from prostate cancer, and it is the most frequently diagnosed cancer in 112 countries.

“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients,” said Jamie Bearse, CEO and president at ZERO – The End of Prostate Cancer.

Prostate-specific membrane antigen (PSMA) biomarkers are crucial for evaluating the progression of metastatic prostate cancer and are highly expressed in more than 80% of patients with prostate cancer.

To help identify patients who may be eligible for targeted treatment with Pluvicto, the FDA has also approved Locametz, an imaging agent that can identify lesions in adult patients using a PET scan. Locametz can identify tumour lesions presenting PSMA biomarkers and locate tumours that may have spread to soft tissue, lymph nodes, or bone in the body.

Article by
Fleur Jeffries

24th March 2022

From: Regulatory



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