The US agency has also approved complementary diagnostic imaging agent Locametz, to identify patients eligible for treatment using Pluvicto
Novartis seeks EMA authorisation for both Pluvicto and Locametz. (Credit: Novartis AG)
Novartis has received approval from the US Food and Drug Administration (FDA) for its Pluvicto (lutetium Lu 177 vipivotide tetraxetan) to treat a type of metastatic prostate cancer.
The therapy was indicated for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC) in adults, who were previously treated with other cancer therapies.
Pluvicto is a targeted radioligand therapy that combines a targeting ligand with a therapeutic radioisotope.
According to the Swiss drugmaker, it is the first targeted radioligand therapy to receive FDA approval for the treatment of eligible mCRPC patients.
The company is planning to commercialise radioligand therapy in the next few weeks.
Novartis Oncology president Susanne Schaffert said: “With our unique strategy to tackle cancer by leveraging four therapeutic platforms, I am thrilled that with Pluvicto, we are bringing the targeted RLT platform to bear for treating eligible patients with mCRPC.
“Today’s approval builds upon our history in prostate cancer, a devastating disease where we believe our innovation can make a meaningful difference to patients.”
In addition to the radioligand therapy, the US health agency has approved Locametz, a diagnostic preparation kit for gallium Ga 68 gozetotide injection.
Upon radiolabelling, the imaging agent aids the identification of PSMA-positive lesions in mCRPC patients, using a positron emission tomography (PET) scan.
Locametz identifies patients eligible for Pluvicto treatment by detecting the tumour lesions and locates the tumours that may have spread across the body.
The FDA approval of Pluvicto is supported by the positive results from the Phase 3 VISION trial in PSMA-positive mCRPC patients previously treated with chemotherapy.
In the study, the participants who received Pluvicto plus standard of care (SOC) had experienced improved overall survival (OS) compared to SOC alone.
Pluvicto plus SOC showed a 38% of reduction in risk of death and a statistically significant reduction in the risk of radiographic disease progression or death (rPFS).
The most common adverse events include fatigue, dry mouth, nausea, low red blood cell counts (anaemia), decreased appetite, and constipation.
Novartis said that it is seeking marketing authorisation for both Pluvicto and Locametz, from the European Medicines Agency and other health agencies worldwide.