Swiss drugmaker Novartis has received the US Food and Drug Administration (FDA) approval for Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat advanced prostate cancer.
Pluvicto is an intravenous radioligand therapy (RLT) that combines a targeting compound with a therapeutic radionuclide, lutetium-177.
Once administered, Pluvicto binds to prostate cancer cells expressing prostate-specific membrane antigen (PSMA).
The radioisotope’s energy emissions damage the target cells and nearby cells, disrupting their ability to replicate and inducing cell death.
Pluvicto is indicated for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC).
The drug is approved specifically for those who have undergone androgen receptor pathway inhibitor (ARPI) therapy and are suitable to delay chemotherapy.
Novartis US president Victor Bultó said: “Today’s approval for an expanded indication for Pluvicto brings more choice to nearly three times as many patients, enabling us to further establish radioligand therapies as a pillar in cancer care.
“As pioneers in the RLT space, Novartis is committed to providing education, resources, and practical solutions to healthcare providers to help ensure access for all patients navigating this challenging disease.”
Based on two Phase 3 studies, Pluvicto is the only PSMA-targeted agent shown to significantly improve radiographic progression-free survival (rPFS).
Also, the drug showed a safety profile with proven tolerability in both pre- and post-taxane settings for patients with ARPI-treated, PSMA-positive mCRPC.
The expanded indication, which increases the number of eligible patients by threefold, is supported by results from the Phase 3 PSMAfore trial.
In the study, Pluvicto reduced the risk of radiographic progression or death by 59% compared to a change in ARPI in patients with PSMA-positive mCRPC after ARPI therapy.
Also, the drug more than doubled median rPFS in an updated exploratory analysis.
Additional findings indicated that Pluvicto maintained a consistent and favourable safety profile, without impairing patients’ ability to undergo subsequent chemotherapy.
The most common adverse events include dry mouth, fatigue, nausea, and constipation.
Novartis is also investigating Pluvicto in earlier stages, including metastatic hormone-sensitive prostate cancer and oligometastatic prostate cancer, under the PSMAddition study.
The US study principal investigator Michael Morris said: “The earlier indication for Pluvicto could really change our treatment paradigms for patients with mCRPC.
“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.”
