A Novartis drug that delivers a targeted dose of radiation to a prostate cancer patient’s tumor has now been approved, offering a treatment option for severe cases that cannot be treated with surgery and have progressed despite earlier lines of treatment.
This FDA decision The Wednesday announcement covers adults whose cancers are positive for prostate-specific membrane antigen (PSMA), a protein that is abundant on the surface of prostate cancer cells. Novartis Therapeutics Pluvicto is what is called a radioligand. The infusion therapy consists of a beta particle, lutetium 177, which is attached to a ligand that binds to PSMA. By targeting the delivery of radioactive particles, the method aims to limit damage to healthy tissue.
Novartis says Pluvicto will become available in the next few weeks. Concurrent with the approval of the new prostate cancer treatment, the FDA also authorized Locametz, an injectable radioactive diagnostic agent for the detection of PSMA-positive lesions, including those in patients with prostate cancer.
The approval of Pluvicto is based on results from an open-label Phase 3 study that enrolled men with PSMA-positive metastatic prostate cancer. Participants were randomly assigned to receive Pluvicto plus best standard of care, or best standard of care alone. The key primary objective is to measure overall survival, which is how long patients live after starting the experimental treatment. The results showed that the median overall survival in the treatment group was 15.3 months, compared with 11.3 months in the standard-of-care group. Adverse events commonly reported in the Pluvicto arm of the study included fatigue, dry mouth, nausea and anemia. Novartis reported preliminary data from the study last year Just before the annual meeting of the American Society of Clinical Oncology.
Pluvicto is a key part of it Novartis to buy Endocyte for $2.1 billion in 2018. Novartis has more plans for this asset. The company has submitted marketing authorizations for Pluvicto and Locametz in Europe. In addition, two phase 3 studies are evaluating radiopharmaceuticals in metastatic prostate cancer with the aim of moving therapy to earlier lines of treatment.
Public domain image from the National Cancer Institute
