FDA approval for castration-resistant prostate cancer
pharmafile | March 24, 2022 | News story | Business Services |
The FDA has approved Novartis’ prostate cancer treatment, Pluvicto™, which is now expected to become available in a few weeks. The drug has been approved for the treatment of adult patients with a type of advanced cancer that has spread to other parts of the body.
The news makes Pluvicto the first FDA-approved targeted radioligand therapy (RLT) for eligible patients with mCRPC that combines a targeting compound (ligand) with a therapeutic radioisotope (a radioactive particle).
The cancer, called prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer (PSMA-positive mCRPC), is not responsive to hormone therapy in slowing or stopping the disease.
Androgen deprivation therapy (ADT) works by blocking testosterone from stimulating the cancer to continue growing. “castration resistant” refers to cancer that is no longer responding to this kind of therapy.
“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,” said Oliver Sartor, MD, Medical Director at Tulane Cancer Center. “Pluvicto is a step forward in the evolution of precision medicine for prostate cancer.”
The approval of Pluvicto (lutetium Lu 177 vipivotide tetraxetan) was based off results from a Phase III trial demonstrating patients treated with the drug plus standard available treatment had a 38% reduction in the risk of death, and statistically significant reduction in the risk of radiographic disease progression or death, compared to standard of care alone.
“Prostate cancer is the second leading cause of cancer-related death in Americans with a prostate gland. Although the treatment landscape for mCRPC continues to evolve, there is a high unmet need for additional precision medicine treatment options to improve outcomes for these patients,” said Jamie Bearse, CEO and President at ZERO – The End of Prostate Cancer.
“The approval of Pluvicto offers new hope to the mCRPC community.”
Ana Ovey
