Novartis Radioligand Therapy for the Treatment of Prostate Cancer Receives FDA Breakthrough Therapy Designation

On June 16, 2021, Novartis announced that the US FDA has granted its potential "first-in-class" targeted radioligand therapy (radioligand therapy, RLT) 177Lu-PSMA-617 breakthrough therapy designation for Treatment of prostate specific membrane antigen (PSMA) positive castration resistant prostate cancer (mCRPC)

In recent years, radiopharmaceuticals are becoming an important direction in the field of precision tumor therapy

▲Introduction to 177Lu-PSMA-617 therapy (picture source: Novartis official website)

This breakthrough therapy designation is based on the positive results of the ongoing randomized, double-blind, open-label, multi-center Phase 3 clinical trial VISION

According to the data released at the ASCO annual meeting in 2021, the median overall survival of the patient was extended by 4 months, the risk of death was reduced by 38% (HR=0.

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Reference materials:

[1] Breakthrough Therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC).

[2] FDA Grants Breakthrough Therapy Designation to 177Lu-PSMA-617 for mCRPC.