Novartis’ Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan) has been approved by the European Commission (EC) for the treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
The approval, which follows a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use in October, will be applicable to patients who have been previously treated with AR pathway inhibition and taxane-based chemotherapy.
The company’s application was supported by results from the pivotal phase 3 VISION trial in which these patients receiving Pluvicto plus best standard of care (BSoC) had a 38% reduction in the risk of death and a 60% reduction in the risk of radiographic disease progression or death (rPFS) compared to BSoC alone.
Moreover, 30% of patients with evaluable disease at baseline demonstrated an objective response with Pluvicto plus BSoC, compared to the 2% in the BSoC-alone arm.
Prostate cancer is the most frequently diagnosed cancer in 112 countries, with more than 1.4 million new cases and 375,000 deaths in 2020 alone.
The majority of patients diagnosed with CRPC already present with metastases at time of diagnosis. Despite recent advances, however, patients with metastatic prostate have an approximate three in ten chance of surviving five years, underscoring the need for new targeted treatment options to help improve long-term outcomes.
More than 80% of patients highly express a phenotypic biomarker called PSMA, making it a promising diagnostic and therapeutic target for radioligand therapy, Novartis said.
Haseeb Ahmad, president, Europe, Novartis, said the approval marked “a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease”.
He continued: “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.”
The company also announced positive results from its pivotal phase 3 PSMAfore study of Pluvicto in this same patient population earlier this month.
The trial met its primary endpoint, with Pluvicto demonstrating a statistically significant and clinically meaningful improvement in rPFS after treatment with androgen-receptor pathway inhibitor (ARPI) therapy, compared to a change in ARPI.
No unexpected safety findings were observed in the latest study, the company said, with the results consistent with the established safety profile of Pluvicto.