A newly expanded prostate cancer drug could bring new hope to patients with a common form of the disease.
Novartis, a Switzerland-based pharmaceutical company, announced on March 28 that the U.S. Food and Drug Administration (FDA) has expanded approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan), a targeted radioligand therapy (RLT) that is given before chemotherapy.
(RLTs are a form of targeted nuclear medicine that doctors use to treat multiple types of cancer, according to Novartis.)
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The drug is intended for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC) who have received one round of androgen receptor pathway inhibitors (ARPIs), a class of drugs used in the treatment of metastatic prostate cancer.
Pluvicto first got FDA approval on March 23, 2022, but this new expanded approval triples the number of patients eligible to receive the drug, according to a Novartis press release.
The drug is administered through an IV into the bloodstream, where it attaches to prostate cancer cells and either keeps them from replicating or kills them.
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“The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC,” said lead study author Michael Morris, MD, prostate cancer section head at Memorial Sloan Kettering Cancer Center in New York.
“It offers a targeted therapy that better delays disease progression compared to a second ARPI. This approval is a significant step forward and should open the doorway to a therapy that has clear clinical advantages for the patient with mCRPC who has progressed on one ARPI and has not received chemotherapy.”
In clinical trials, Pluvicto “significantly reduced the risk of progression or death” by 59%.
This is a form of prostate cancer that has spread to other parts of the body and does not respond to standard hormone therapy, according to WebMD.
It also has high levels of prostate-specific membrane antigen (PSMA), a protein produced by prostate cancer cells.
In clinical trials, Pluvicto “significantly reduced the risk of progression or death” by 59% in mCRPC patients, Novartis reported.
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“The FDA’s expanded approval of [lutetium Lu 177 vipivotide tetraxetan] marks a transformative step forward in the treatment of mCRPC, underscoring the growing impact of precision oncology,” Jorge A. Garcia, MD, a genitourinary medical oncologist and chair of the Solid Tumor Oncology Division at University Hospitals Seidman Cancer Center/Case Western Reserve University in Cleveland, Ohio, told OncLive.
“By enabling access to this targeted radioligand therapy prior to chemotherapy, we are not only broadening treatment options, but also redefining the standard of care for PSMA-positive disease.”
Prostate cancer is the second leading cause of death among men; mCRPC makes up a majority of the deaths and 20% of all metastatic prostate cancer cases.
Studies have shown that approximately 10% to 20% of patients with prostate cancer develop mCRPC within five years of follow-up after initial therapy, and cases of metastatic patients have risen 4% to 5% each year since 2011.
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Sixty percent of prostate cancers are diagnosed in men who are 65 or older, according to the American Cancer Society. The risk of being diagnosed with metastatic prostate cancer typically occurs between 65 and 74.
Adverse effects of Pluvicto included dry mouth (61%), fatigue (53%), nausea (32%) and constipation (22%), the release stated.
The patients receiving the drug were able to proceed with chemotherapy after taking it.
Novartis is committed to delivering Pluvicto to the nearly 600 RLT treatment sites in the U.S., the company stated.
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Looking ahead, Novartis said it plans to investigate the use of RLTs for other types of advanced cancers, including breast, colon, neuroendocrine, lung and pancreatic cancers.
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