A Novartis drug that delivers a targeted dose of radiation to the tumors of prostate cancer patients is now approved, providing a treatment option for serious cases that can’t be treated surgically and have advanced despite earlier lines of therapy.

The FDA decision announced Wednesday covers adults whose cancer is positive for prostate-specific membrane antigen (PSMA), a protein abundant on the surface of prostate cancer cells. The Novartis therapy, Pluvicto, is what’s called a radioligand. The infused therapy is comprised of a beta particle, lutetium 177, attached to a ligand that binds to PSMA. By targeting the delivery of the radioactive particle, the approach is meant to limit damage to healthy tissue.

Novartis said Pluvicto will become available in coming weeks. Concurrent with approval of the new prostate cancer treatment, the FDA also authorized Locametz, an injectable radioactive diagnostic agent for finding PSMA-positive lesions, including those in prostate cancer patients.

The Pluvicto approval is based on the results of an open-label Phase 3 study enrolling men with PSMA-positive metastatic prostate cancer. Participants were randomly assigned to receive Pluvicto plus the best standard of care, or the best standard of care alone. The key main goal was to measure overall survival, which is how long patients lived after the starting on the experimental therapy. The results showed that the treatment group posted a median overall survival of 15.3 months compared to a median 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 prior to the annual meeting of the American Society of Clinical Oncology.

Pluvicto was the key part of Novartis’s $2.1 billion acquisition of Endocyte in 2018. Novartis has more planned for the asset. The company has submitted for marketing authorizations in Europe for both Pluvicto and Locametz. Also, two Phase 3 studies are underway evaluating the radiopharmaceutical in metastatic prostate cancer, with the goal of moving the therapy into earlier lines of treatment.

Public domain image via the National Cancer Institute