Drug Shortage of Prostate Cancer Treatment Pluvicto Resolved, FDA Finds

The shortage of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) — a PSMA-targeted therapy that was approved by the Food and Drug Administration (FDA) in 2022 for the treatment of patients with metastatic castration-resistant prostate cancer — has been resolved, according to the agency.

The shortage of the radiopharmaceutical drug Pluvicto lasted nearly eight months, running from March 7 until Oct. 25 of this year, per the agency’s website.

“We have been working hard to increase the capacity and improve the reliability of the supply of our radioligand therapies to ensure patients have access to this therapy and to prepare for future growth as more patients may become eligible for this treatment,” said Victor Bulto, president of Pluvicto manufacturers Novartis US, in a news release. “Radioligand therapies have the potential to shift the standard of care in oncology and we are excited about the possibilities of our broad RLT pipeline for patients. With substantial experience in developing a reliable supply chain and delivery infrastructure, we are well positioned to expand access to these therapies for years to come.”

The weekly production capacity of Pluvicto has more than doubled since May, according to the news release, with the company describing the supply of the drug as “unconstrained” since the FDA’s approval earlier this year of commercial production of Pluvicto at the company’s Millburn, New Jersey, facility.

Novartis, the company announced, has “more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly,” and the manufacturer further noted that availability is expected to continue to expand into next year with production ramping up at sites in New Jersey and Indiana.

Discussing the FDA approval of Pluvicto with CURE® last year, Dr. Richard Wahl, president of the Society of Nuclear Medicine and Molecular Imaging and director of the Mallinckrodt Institute of Radiology at Washington University School of Medicine in St. Louis, explained the science behind Pluvicto and its potential impact for patients with metastatic castration-resistant prostate cancer.

“This therapy is truly a targeted therapy. The radioactive Lu-177 molecules that are a part of Pluvicto (hone) into the tumors,” Wahl said. “This new nuclear medicine therapy is offered to patients who have developed cancers that are resistant to hormonal therapy and who have received taxane-based chemotherapy but whose cancer has still progressed.”

PSMA, as Wahl told CURE®, is a protein that is overexpressed on the surface of many prostate cancer cells. Patients with PSMA-positive cancers can receive Pluvicto and the drug delivers targeted radiation directly to the tumors.

“The precise targeting means that the radioactive molecules selectively accumulate in cancers (rather than) normal tissues,” Wahl said.

Research findings were presented at the 2023 ASCO GU Cancers Symposium showing that patients with metastatic castration-resistant prostate cancer who received treatment with Pluvicto within six months of having received radium-223 tolerated the regimen, with outcomes comparable to those who waited for the administration of Pluvicto.

Trial results presented at the 2023 ESMO Congress showed that treatment with Pluvicto improved progression-free survival (the time a patient lives without their disease progressing or worsening) and had a favorable safety profile among patients with metastatic castration-resistant prostate cancer who were taxane-naïve.

More than 200 facilities in the United States have been certified to administer Novartis’ radioligand therapies such as Pluvicto, with the company planning to add approximately 130 additional facilities to that roster, according to its news release.

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