The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion and recommended a marketing authorisation for Novartis’ Pluvicto (177Lu-PSMA-617 or lutetium vipivotide tetraxetan) to treat prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
The regulator has recommended the radioligand therapy along with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition to treat progressive PSMA- positive mCRPC adult patients, who have received treatment with AR pathway inhibition and taxeme based chemotherapy.
This opinion is based on the data obtained from the prospective, randomised, open-label, multicentre, international Phase III VISION study.
The study was designed for evaluating the safety and efficacy of Pluvicto (lutetium (177Lu) vipivotide tetraxetan) along with investigator-chosen standard of care (BSoC) compared to BSoC.
It was conducted in PSMA PET-scan positive mCRPC patients who have received androgen receptor (AR) pathway inhibition as well as taxane-based chemotherapy.
In the trial, Pluvicto and BSoC combination showed significantly improved overall survival in PSMA-positive mCRPC patients.
Novartis chief commercial officer and Innovative Medicines International president Marie-France Tschudin said: “This positive CHMP opinion for Pluvicto is an important step forward in our goal of bringing transformative innovation to more patients around the world.
“If approved by the European Commission, Pluvicto would be the first and only commercial radioligand therapy for people with advanced prostate cancer in Europe.
“We are committed to exploring the potential of radioligand therapy to address unmet needs in prostate cancer, including in earlier stages of disease.”
The findings showed that Pluvicto plus BSoC treated group had 60% reduction in the radiographic disease progression or death (rPFS) risk and 38% reduction in death risk compared to BSoC alone.
Decreased appetite, anemia, fatigue, nausea, dry mouth and constipation are the most common adverse events in the study’s Pluvicto arm.
The regulatory decision is expected to come in about two months.