NEW YORK – The European Medicine Agency's Committee for Medicinal Products for Human Use (CHMP) on Friday recommended approval for Novartis' Pluvicto (177Lu-PSMA-617 or lutetium vipivotide tetraxetan) combined with androgen deprivation therapy for patients with previously treated metastatic castration-resistant prostate cancer whose tumors express the prostate-specific membrane antigen (PSMA).
Pluvicto should be given to patients after an androgen receptor pathway inhibitor and taxane-based chemotherapy. Further, the radioligand treatment should be combined with androgen deprivation therapy with or without an androgen receptor pathway inhibitor, CHMP recommended.
The committee based its opinion on the results of the Phase III VISION trial, in which mCRPC patients on Pluvicto had a 38 percent reduction in the risk of death and a 60 percent reduction in the risk of radiographic disease progression or death compared to patients on the best available standard of care.
The positive recommendation for Pluvicto in Europe comes after the US Food and Drug Administration approved the therapy in March for patients with previously treated, progressive mCRPC whose tumors express PSMA as determined by Novartis' imaging agent Locametz (gallium Ga 68 gozetotide).
The FDA-approved indication does not mention combining Pluvicto with androgen deprivation therapy and an androgen deprivation pathway inhibitor, as the CHMP is recommending. However, in the US and Europe, Pluvicto is intended for previously treated mCRPC patients, though Novartis is evaluating the therapy in earlier lines and for patients with earlier stages of prostate cancer.
The European Commission will now review CHMP's opinion and decide in roughly two months whether to approve Pluvicto throughout the European Union.