FDA’s Approval of Pluvicto Gives Some Patients With Prostate Cancer a ‘Truly Targeted Therapy’ With Modest Side Effects


A recently FDA-approved drug offers patients with metastatic castration-resistant prostate cancer a newer treatment that improves survival, but is not curative of the disease, which means that more research is needed, according to an expert.

The Food and Drug Administration’s (FDA) recent approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan, formerly referred to as 177Lu-PSMA-617), the first PSMA-targeted therapy, gives patients with metastatic castration-resistant prostate cancer a new treatment option that prolongs survival, according to an expert.

In a recent interview with CURE®, 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 recently discussed the impact that Pluvicto’s approval can have for this group of patients.

“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.”

Wahl explained that PSMA is a protein that is overexpressed on the surface of many prostate cancer cells, and its presence allows clinicians to see the prostate cancer on PET scans with the help of agents that are directed at PSMA. Once the PSMA-positive cancer is found, patients can receive Pluvicto, which delivers targeted radiation directly to the tumors, largely sparing the healthy cells around it.

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

Pluvicto is well tolerated, according to Wahl, who said that the drug has “relatively modest side effects when directly compared to those of chemotherapy.”

Common side effects from Pluvicto include fatigue and loss of appetite. Also, Wahl said that patients may experience drops in their red and white blood cell counts or dry mouth, which may lead to them being prescribed a lower dose.

Patients should discuss any other health complications with their doctor before starting Pluvicto, as those with low blood counts may be less suitable for the drug, Wahl said. Additionally, patients with kidney issues — especially renal obstruction — would need particular attention from their health care providers to determine if they are eligible. Those with incontinence (a lack of control of their bladder and bowels) should be closely monitored, according to Wahl.

Pluvicto’s FDA approval is a step forward in the treatment of prostate cancer, but as Wahl cautioned, more work needs to be done.

“While the new therapy is very exciting and important, the VISION trial showed a 38%reduced risk of death and a 60% reduced risk of progression. These are good, but the overall extension of survival was from 11.3 to 15.3 months — thus, this was not curative, and there is much more to do in this space with additional innovation so that survival can be extended,” Wahl said, noting that nuclear medicine still has a way to go in both prostate cancer and other malignancies.

“Nuclear medicine therapies are effective, and there is great opportunity to offer more of these treatments earlier in the course of prostate cancer therapy and forward in other diseases,” concluded. “The ability to precisely image with PET or (single-photon emission computerized tomography) scans — and the ability to quantify the delivery of internally delivered radioactivity to tumors and normal tissues using dosimetry — may help us further improve on these innovative treatments by allowing for personalized dosing approaches in the future.”

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