FDA approves Pluvicto for certain men with advanced prostate cancer
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The FDA approved lutetium Lu 177 vipivotide tetraxetan for treatment of certain men with advanced prostate cancer.
The approval applies to those with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant disease who received prior androgen receptor pathway inhibition and taxane-based chemotherapy.
Lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis) — formerly called 177Lu-PSMA-617 — is the first targeted radioligand therapy for treatment of progressive, PSMA-positive metastatic castration-resistant prostate cancer.
PSMA is highly expressed in more than 80% of men with prostate cancer.
“The approval of Pluvicto is an important clinical advancement for people with progressing [metastatic castration-resistant prostate cancer], as it can significantly improve survival rates for those who have limited treatment options,” Oliver Sartor, MD, medical director at Tulane Cancer Center, said in a Novartis-issued press release. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”
The FDA based the approval on results of the randomized phase 3 VISION study, which included 831 men with PSMA-positive metastatic castration-resistant prostate cancer previously treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
As Healio previously reported, results presented during the plenary session of last year’s virtual ASCO Annual Meeting showed the addition of lutetium Lu 177 vipivotide tetraxetan to standard care significantly extended OS (median, 15.3 months vs. 11.3 months; HR = 0.62; 95% CI, 0.52-0.74) and radiographic PFS (median, 8.7 months vs. 3.4 months; HR = 0.4; 99.2% CI, 0.29-0.57).
The most common adverse events among men assigned lutetium Lu 177 vipivotide tetraxetan included fatigue (43%), dry mouth (39%), nausea (35%), anemia (32%), decreased appetite (21%) and constipation (20%).
The FDA also approved gallium Ga 68 gozetotide (Locametz, Novartis), a radioactive diagnostic imaging agent for PET of PSMA-positive lesions, to help guide selection of patients with metastatic prostate cancer for whom lutetium Lu 177 vipivotide tetraxetan PSMA-directed therapy is indicated.
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