https://www.novartis.com/news/media-releases/novartis-receives-positive-chmp-opinion-pluvicto-patients-progressive-psma-positive-metastatic-castration-resistant-prostate-cancer
Novartis receives positive CHMP opinion for Pluvicto® for patients with progressive, PSMA-positive metastatic castration-resistant prostate cancer
Basel, October 14, 2022 — Novartis announced today 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.
“People at this advanced stage of disease have already received many different treatments and have few alternatives left,” said Prof. Karim Fizazi, MD, PhD, VISION trial investigator andHead of Medical Oncology at Gustave Roussy, first European cancer center based in Villejuif, France. “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 outcomes1. As a clinician this gives me hope for patients facing a very difficult situation.”
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 alone1.
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 alone1. 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 arm1. The most common adverse events (all grades) in the Pluvicto® arm of the study were fatigue (43%), dry mouth (39%), nausea (35%), anemia (low red blood cell counts) (32%), decreased appetite (21%), and constipation (20%).
“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 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.
About Pluvicto® (lutetium (177Lu) vipivotide tetraxetan)
Despite advances in prostate cancer care, there is a high unmet need for new targeted treatment options to improve outcomes for patients with mCRPC1. 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)1. Pluvicto® delivers radiation to PSMA-positive cells and the surrounding microenvironment1. Pluvicto® was approved by the FDA in March 2022.
Two additional Phase III trials in earlier lines of treatment for metastatic prostate cancer are ongoing, investigating potential clinical utility in the mCRPC pre-taxane setting (PSMAfore)11 and in the metastatic hormone-sensitive setting (PSMAddition)12. Novartis is also evaluating opportunities to investigate Pluvicto® radioligand therapy in earlier stages of prostate cancer.
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