Novartis’ Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan) has been recommended for conditional marketing authorisation (CMA) in the EU for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC), the company announced.
The recommendation is for use of the radioligand therapy in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition in patients who have been treated with AR pathway inhibition and taxane based chemotherapy.
With more than 1.4 million new cases and 375,000 deaths in 2020 alone, prostate cancer is the most frequently diagnosed cancer in 112 countries. More than 80% of patients with prostate cancer highly express a phenotypic biomarker called PSMA, making it a promising diagnostic and therapeutic target for radioligand therapy, according to Novartis.
“If approved in Europe, Pluvicto would represent a new type of precision medicine targeting a biomarker broadly expressed in prostate cancer patients and provide a therapeutic option with demonstrated potential to improve outcomes. As a clinician this gives me hope for patients facing a very difficult situation,” said Professor Karim Fizazi, VISION trial investigator and head of medical oncology at Gustave Roussy.
The decision from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) is based on positive results from the company’s phase 3 VISION study in which Pluvicto plus best standard of care (BSoC) demonstrated ‘significantly improved’ overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.
Specifically, patients treated with Pluvicto plus BSoC had a 38% reduction in risk of death and a 60% reduction in the risk of radiographic disease progression or death compared to BSoC alone. Moreover, 29.8% of patients with evaluable disease at baseline demonstrated an overall response with Pluvicto plus BSoC, compared to 1.7% in the BSoC alone arm.
Commenting on the positive results, Marie-France Tschudin, president, innovative medicines international and chief commercial officer, Novartis, 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.”