Novartis receives European Commission approval for Pluvicto® as the first targeted radioligand therapy for treatment of progressive PSMA–positive metastatic castration-resistant prostate cancer
Novartis has announced the European Commission (EC) approved Pluvicto® (INN: lutetium (177Lu) vipivotide tetraxetan), a targeted radioligand therapy. Pluvicto® is approved in combination with androgen deprivation therapy (ADT) with or without androgen receptor (AR) pathway inhibition, for the treatment of adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC). These patients have been treated with AR pathway inhibition and taxane-based chemotherapy.
The approval follows a positive opinion issued in October by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is applicable to all 27 European Union member states plus Iceland, Norway, Northern Ireland and Liechtenstein.
The EC approval was granted based on results from the pivotal Phase III VISION trial, where participants, previously treated with AR pathway inhibition and taxane based chemotherapy, receiving Pluvicto® plus best standard of care (BSoC) had a 38% reduction in the risk of death and a statistically significant reduction (60%) in the risk of radiographic disease progression or death (rPFS) compared to BSoC alone. About a third (30%) of patients with evaluable disease at baseline demonstrated an objective response (per RECIST 1.1) with Pluvicto® plus BSoC, compared to the 2% in the BSoC-alone arm.
“Today’s approval of Pluvicto® by the European Commission marks a major milestone for patients with advanced prostate cancer who have few alternative treatments at this stage of their disease,” said Haseeb Ahmad, President Europe, Novartis. “We are excited by the potential of Pluvicto® to bring groundbreaking clinical benefits to these patients, transforming cancer care for the third-most diagnosed cancer globally.”
Approximately 473,300 prostate cancer cases and 108,000 prostate cancer-related deaths occurred across Europe in 2020. Patients with metastatic prostate cancer have an approximate 3 in 10 chances of surviving 5 years, indicating a high unmet need for new targeted treatment options for these patients. Novartis is committed to addressing this need by reimagining cancer care with radioligand therapy and precision medicine, with a goal to reduce the global disease burden, extend the lives of patients with prostate cancer and elevate current standards of care.
About Pluvicto® (lutetium (177Lu) vipivotide tetraxetan)
Pluvicto® is an intravenous radioligand therapy combining a targeting compound (a ligand) with a therapeutic radionuclide (a radioactive particle, in this case lutetium-177). After administration into the bloodstream, Pluvicto® binds to target cells, including prostate cancer cells that express PSMA, a transmembrane protein1. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells disrupting their ability to replicate and/or triggering cell death.
Pluvicto® is approved in the US and other countries including Great Britain and Canada to treat adults with a type of advanced cancer called prostate-specific membrane antigen–positive metastatic castration-resistant prostate cancer (PSMA–positive mCRPC) and who have already been treated with other anticancer treatments (androgen receptor pathway inhibition and taxane-based chemotherapy).
Novartis is also evaluating opportunities to investigate Pluvicto® radioligand therapy in earlier stages of prostate cancer.
Source: Novartis
