Novartis gets positive EMA panel opinion for prostate cancer drug Pluvicto
Pluvicto is a radioligand therapy combining a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope
Basel: Novartis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization for Pluvicto (INN: lutetium (177Lu) vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617), a radioligand therapy, in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with progressive prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with AR pathway inhibition and taxane-based chemotherapy.
Pluvicto is a radioligand therapy combining a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope (a radioactive particle, in this case lutetium-177). Pluvicto delivers radiation to PSMA-positive cells and the surrounding microenvironment. Pluvicto was approved by the FDA in March 2022.
The positive CHMP opinion is based on data from the Phase III 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.
Results from the VISION trial demonstrated that participants 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 (rPFS) compared to BSoC alone. In addition, approximately a third (29.8%) of patients with evaluable disease at baseline demonstrated an overall response (per RECIST 1.1) with Pluvicto plus BSoC, compared to 1.7% in the BSoC alone arm.
"This positive CHMP opinion for Pluvicto is an important step forward in our goal of bringing transformative innovation to more patients around the world," said Marie-France Tschudin, President, Innovative Medicines International & Chief Commercial Officer, Novartis. "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 the disease."
The CHMP's positive opinion on Pluvicto in PSMA–positive mCRPC patients will be referred to the European Commission (EC), which will deliver a final decision in approximately two months. The decision will be applicable to all 27 EU member states plus Iceland, Norway, Northern Ireland, and Liechtenstein.
