FDA Approves First PSMA-Targeted Therapy for Metastatic Castration-Resistant Prostate Cancer

The Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617) to treat adults with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer.

This also includes patients who were previously treated with other therapies including androgen receptor pathway inhibitors and taxane-based chemotherapy, according to a press release from Novartis, the manufacturer of Pluvicto.

Pluvicto is the first FDA-approved targeted radioligand therapy for patients with metastatic castration-resistant prostate cancer, which combines a targeting compound with a therapeutic radioisotope, according to the release. In particular, Pluvicto binds to target cells such as prostate cancer cells that express PSMA, which in turn damages the target cells and nearby cells. This disrupts the cells’ ability to replicate, thus causing cell death.

“The approval of Pluvicto is an important clinical advancement for people with progressing (metastatic castration-resistant prostate cancer), as it can significantly improve survival rates for those who have limited treatment options,” said Dr. Oliver Sartor, medical director at Tulane Cancer Center in New Orleans, in the release. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”

This FDA approval is based on results from the phase 3 VISION trial, which demonstrated that Pluvicto plus standard of care improved overall survival compared to standard of care alone in patients with metastatic castration-resistant prostate cancer who were previously treated with taxane-based chemotherapy and an androgen receptor pathway inhibitor.

The findings, which were presented during the 2021 ASCO Annual Meeting, showed that at a median follow-up of 20.9 months, adding Pluvicto improved the median overall survival (time that a patient with cancer is still alive after treatment) by four months over standard of care alone. Pluvicto also led to a 5.3-month improvement in median radiographic progression-free survival (time from randomization to first evidence of radiographic disease progression or death). This translated to a 60% reduction in the risk for progression or death.

The most common side effects observed during the trial in patients treated with Pluvicto include dry mouth (39%), fatigue (43%), anemia (32%), nausea (35%), constipation (20%) and decreased appetite (21%).

“Prostate cancer is the second-leading cause of cancer-related death in Americans with a prostate gland,” said Jamie Bearse, CEO and president at ZERO – The End of Prostate Cancer, in the release. “Although the treatment landscape for (metastatic castration-resistant prostate cancer) 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 (metastatic castration-resistant prostate cancer) community.”

Pluvicto may be available to patients and physicians within weeks, according to the release.

Also included in this FDA approval is Locametz (kit for the preparation of gallium Ga 68 gozetotide injection), which is used to identify lesions that are PSMA positive in adults with metastatic castration-resistant prostate cancer using a positron emission tomography scan. This allows oncologists to see where the tumors may have spread to other areas of the body and which patients may be eligible for targeted therapy with Pluvicto.

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