Novartis wins FDA approval for prostate cancer therapy

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• On Wednesday, the U.S. Food and Drug Administration (FDA) granted the approval for Swiss pharma giant, Novartis (NYSE:NVS) to market its radioligand therapeutic agent Pluvicto as a treatment for certain adult patients with prostate cancer.
• According to labeling information announced by the FDA, Pluvicto identified as lutetium Lu 177 vipivotide tetraxetan in generic terms is approved for intravenous use in prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
• The medication is indicated for patients who have received androgen receptor (AR) pathway inhibition and taxane-based chemotherapy.

• The decision was based on results from the Phase III VISION trial in which the treatment which was formerly called 177Lu-PSMA-617 along with standard of care (SOC) improved overall survival in PSMA-positive mCRPC patients compared to SOC alone.

• Novartis (NVS) added Pluvicto to its pipeline as part of its 2018 acquisition of U.S.-based cancer drugmaker, Endocyte.