Novartis gets European Commission nod for Pluvicto to treat progressive PSMA-positive metastatic castration-resistant prostate cancer

The approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway, Northern Ireland and Liechtenstein.

The EC approval was granted based on results from the pivotal Phase III VISION trial, where participants, previously treated with AR pathway inhibition and taxane based chemotherapy, receiving Pluvicto plus best standard of care (BSoC) had a 38% reduction in the risk of death and a statistically significant reduction (60%) in the risk of radiographic disease progression or death (rPFS) compared to BSoC alone. About a third (30%) of patients with evaluable disease at baseline demonstrated an objective response (per RECIST 1.1) with Pluvicto plus BSoC, compared to the 2% in the BSoC-alone arm.

“The approval of Pluvicto by the European Commission marks a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease,” said Haseeb Ahmad, President Europe, Novartis. “We are excited by the potential of Pluvicto to bring groundbreaking clinical benefits to these patients, transforming cancer care for the third-most diagnosed cancer globally.”

Approximately 473,300 prostate cancer cases and 108,000 prostate cancer-related deaths occurred across Europe in 2020. Patients with metastatic prostate cancer have an approximate 3 in 10 chances of surviving 5 years, indicating a high unmet need for new targeted treatment options for these patients.

Read also: Novartis prostate cancer therapy Pluvicto bags European Commission nod