FDA Expands Use of Novartis' Cancer Drug Pluvicto to Earlier Stage Prostate Cancer

The FDA has approved Pluvicto, Novartis’ radiopharmaceutical therapy, for broader use in men with metastatic prostate cancer. Previously reserved for post-chemotherapy treatment, it can now be prescribed before chemotherapy, after patients have received androgen receptor pathway inhibitors (ARPIs). The updated approval triples the number of eligible patients, provided their cancer is castration-resistant and shows the PSMA protein.

In a late-stage clinical trial, Pluvicto was shown to cut the risk of disease progression or death by 59% when compared to switching patients to another ARPI. However, the overall survival difference wasn’t statistically significant — largely due to many patients in the control group crossing over to receive Pluvicto later. A follow-up analysis adjusting for that crossover suggested a 41% reduction in the risk of death, though these results are considered less definitive.

Pluvicto, which Novartis acquired through its purchase of Endocyte in 2018, is part of a rising class of treatments known as radiopharmaceuticals. These therapies combine cancer-targeting molecules with radioactive isotopes designed to seek out tumor markers like PSMA. While promising, radiopharmaceuticals are notoriously complex to manufacture and deliver, due to the short half-life of the radioactive materials involved.

Novartis previously faced production setbacks but says it has resolved those issues. The company is now expanding its Indianapolis facility and building a new plant in California to keep up with increased demand. It claims to have the infrastructure to deliver Pluvicto to nearly 600 treatment sites across the U.S., usually within five days.

Pluvicto generated $1.4 billion in sales, and Novartis is banking on the expanded indication to eventually push that figure beyond $5 billion annually. The company has also started television advertising to support broader awareness and uptake.