Aug. 1 at 2:06 AM
Novartis announced that the FDA has approved Pluvicto in combination with an androgen receptor pathway inhibitor for patients with PSMA-positive metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on the Phase III PSMAddition trial, where the combination reduced the risk of disease progression or death by 28% versus standard care alone, with an updated analysis showing a 33% reduction and a favorable trend in overall survival, although final survival data are still pending.
The expanded label extends Pluvicto's use beyond metastatic castration-resistant prostate cancer, making it available across all stages of PSMA-positive metastatic prostate cancer and nearly doubling the eligible patient population. Novartis noted that more than 186,000 men are diagnosed with mHSPC globally each year, with PSMA expressed in over 80% of prostate cancer patients.,
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