FDA Approves First Targeted Radioligand Therapy for Advanced Prostate Cancer

Novartis‘ proposed drug for adults diagnosed with a certain type of advanced prostate cancer has been given the green light for commercialization.

The U.S. Food and Drug Administration approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for use in adults with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) that has already metastasized to other body parts. These patients have already undergone taxane-based chemotherapy and androgen receptor pathway inhibition without success. 

The regulator’s approval marks a key clinical achievement for people with progressing mCRPC who would otherwise have no alternative forms of treatment. The five-year survival rate for patients is only around 15%, indicating the urgency of a more stable form of therapy. 

Pluvicto is the first FDA-approved targeted radioligand therapy (RLT), combining a targeting compound with a therapeutic radioisotope. It is expected to be available to patients and physicians in the next weeks. 

“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland13. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients. The approval of Pluvicto offers new hope to the mCRPC community,” commented Jamie Bearse, the chief executive officer and president of ZERO – The End of Prostate Cancer, in a statement. 

In addition to Pluvicto, the FDA approved Locametz, the kit needed to prepare the gallium Ga 68 gozetotide injection, which may be used to identify tumor lesions that express the PSMA biomarker and locate where the tumors might have spread. This helps physicians determine which patients are eligible for Pluvicto’s targeted treatment. PSMA is highly expressed in over 80% of patients diagnosed with prostate cancer, making it an essential biomarker for evaluating the extent of disease progression. Like Pluvicto, Locametz is expected to be out in the market in the next weeks. 

The FDA’s decision on Pluvicto follows positive results from the Phase III VISION trial, which demonstrated improved overall survival in patients compared to the standard of care (SOC) alone. Around 30% of the patients with evaluable disease measured at baseline showed an overall response with Pluvicto plus the standard of care, compared to only 2% in the SOC-alone arm. This was measured using RECIST 1.1. Common adverse events included fatigue, nausea, dry mouth, anemia, constipation and decreased appetite. The study had 831 participants.

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“Today’s approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients,” said Dr. Susanne Schaffert, the president of Novartis Oncology, in the same press release. 

Novartis announced that patients may get in touch with AAA PatientCONNECT for support to improve access to the therapies. Pluvicto and Locametz are registered under Advanced Accelerator Applications, which is Novartis’ radioligand unit and is approved for use in the U.S. Novartis has already submitted marketing authorization applications for both to the European Medicines Agency and other health regulators worldwide.