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Novartis announced today that the U.
S.
Food and Drug Administration (FDA) has approved the company’s targeted radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly known as 177Lu-PSMA-617) for the treatment of prostate-specific membrane antigen (PSMA).
) in patients with metastatic castration-resistant prostate cancer (mCRPC)
.
They had been treated with taxane-based chemotherapy and androgen receptor signaling pathway inhibitors
In recent years, radiopharmaceuticals have become an important direction in the field of precision tumor therapy
.
Novartis' Pluvicto links small-molecule compounds that bind PSMA to radioisotopes
▲Introduction to Pluvicto (177Lu-PSMA-617) therapy (Image source: Novartis official website)
This approval is based on positive results from a pivotal Phase 3 clinical trial
.
Trial results showed that the addition of Pluvicto reduced the risk of death by 38% compared to standard treatment, and Pluvicto also significantly reduced the risk of radiological disease progression or death
References:
References:[1] Novartis PluvictoTM approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.
[1] Novartis PluvictoTM approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer.
