FDA Approves Novartis’ Pluvicto for Advanced Prostate Cancer

The FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (mCRPC).

Pluvicto (formerly referred to as 177Lu-PSMA-617) is the first FDA-approved targeted radioligand therapy for eligible patients with mCRPC that combines a targeting compound with a therapeutic radioisotope. Pluvicto is expected to be available to physicians and patients within weeks.

The FDA has also approved a complementary diagnostic imaging agent, Locametz, after radiolabeling with gallium-68 for the identification of PSMA-positive lesion. After radiolabeling, this imaging agent may be used to identify PSMA-positive lesions in adult patients with mCRPC through a positron emission tomography scan.

PSMA is highly expressed in more than 80% of patients with prostate cancer, making it an important phenotypic biomarker for assessing the progression of metastatic prostate cancer. Locametz is expected to be available to physicians and patients within weeks.

Oliver Sartor, M.D.

“The approval of Pluvicto is an important clinical advancement for people with progressing mCRPC, as it can significantly improve survival rates for those who have limited treatment options,” Oliver Sartor, M.D., medical director at Tulane Cancer Center, said in a press release. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”

The approval is based on the results of the phase 3 VISION trial, which demonstrated Pluvicto plus standard of care had a 38% reduction in risk of death and a statistically significant reduction in the risk of radiographic disease progression or death compared with stand of care alone.

Two pivotal phase 3 studies evaluating Pluvicto in earlier lines of treatment for metastatic prostate cancer are under way, with a goal to move into earlier stages of disease.

Pluvicto and Locametz are registered products of Advanced Accelerator Applications, the radioligand business of Novartis.