CHMP recommends Pluvicto® for treating advanced prostate cancer

CHMP issues positive opinion on Pluvicto®, paving the way for it to become the first European-approved radioligand therapy for metastatic prostate cancer patients.


Novartis announced that The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Pluvicto® radioligand therapy for treatment of patients with prostate cancer.

Pluvicto combines a targeting compound (ligand, in this case directed to PSMA) with a therapeutic radioisotope (in this case lutetium-177). Pluvicto delivers radiation to PSMA-positive cells and the surrounding microenvironment.

Used in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, Pluvitco is used to treat 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.

A Phase III trial showed Pluvicto improved survival for patients with pre-treated PSMA-positive mCRPC. Currently, two Phase III trials are underway to evaluate Pluvicto® for treatment in earlier stages of metastatic prostate cancer.

Results from the so-called VISION trial demonstrated that participants treated with Pluvicto, along with the best standard of care (BSoC), had a 38 percent reduction in risk of death and a 60 percent reduction in the risk of radiographic disease progression (rPFS) compared to BSoC alone. The most common adverse events (all grades) in the Pluvicto® part of the study were fatigue, dry mouth, nausea, anaemia (low red blood cell counts), decreased appetite and constipation.

The results from VISION study showed that Pluvicto plus BSoC, significantly improved overall survival in PSMA-positive mCRPC patients previously treated with AR pathway inhibition and taxane-based chemotherapy compared to BSoC alone.

Professor Karim Fizazi, VISION trial investigator and Head of Medical Oncology at Gustave Roussy cancer centre in France, explained that “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.”

Marie-France Tschudin, President, Innovative Medicines International & Chief Commercial Officer, Novartis, commented: “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 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.