**Novartis’ radioligand therapy Pluvicto (lutetium Lu 177 vipivotide tetraxetan) has been approved by the US Food and Drug Administration (FDA) for expanded prostate cancer use.**
The drug has been approved to treat prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) in patients who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay taxane-based chemotherapy.
The authorisation approximately triples the number of patients eligible to receive Pluvicto, which was previously only approved for PSMA-positive mCRPC patients previously treated with both an ARPI and taxane-based chemotherapy.
Around 313,780 new cases of prostate cancer will be diagnosed in the US this year, according to the American Cancer Society’s estimates.
While hormone therapy and chemotherapy are essential treatments for mCRPC, Novartis outlined that many patients and their healthcare providers prefer to avoid or delay chemotherapy due to its side effects, and treatment guidelines recommend avoiding the use of multiple ARPIs.
Administered intravenously into the bloodstream, Novartis’ Pluvicto attaches to prostate cancer cells that express PSMA. Once bound, energy emissions from the radioisotope damage the target cells and nearby cells, disrupting their ability to replicate and/or triggering cell death.
The FDA’s latest decision on the therapy was supported by positive results from the late-stage PSMAfore trial, in which Pluvicto reduced the risk of radiographic progression or death by 59% compared to a change in ARPI in patients with PSMA-positive mCRPC after treatment with ARPI therapy.
Additionally, at an updated exploratory analysis, Pluvicto more than doubled median radiographic progression-free survival, at 11.6 months versus 5.6 months, and the drug demonstrated a consistent and favourable safety profile.
Principal investigator of the study in the US, Michael Morris, Memorial Sloan Kettering Cancer Center, 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.”