Dive Brief:

• Novartis has won Food and Drug Administration approval to sell a radiopharmaceutical designed to treat a form of advanced prostate cancer in a key step forward for an area of research the Swiss drugmaker has prioritized in recent years.

• The FDA cleared the infusion, known as Pluvicto, based on study results showing it could cut the risk of death and slow tumor growth in some of the sickest patients. Participants in the trial had already received other treatments and needed a new option to fight the spread of cancer cells.

• U.S. regulators also approved Novartis’s diagnostic imaging agent, Locametz, which is designed to help doctors find patients eligible for treatment with Pluvicto, Novartis said in a statement. Locametz is used in a PET scan to identify men whose cancer expresses a certain biomarker.

Dive Insight:

Pluvicto is part of Novartis’s larger push into nuclear medicine and other cutting-edge technologies. The Swiss drugmaker picked up the therapy as part of its $2.1 billion purchase of Endocyte in 2018, following on the heels of its $3.9 billion acquisition of radiopharmaceutical specialist Advanced Accelerator Applications.

Radiopharmaceuticals are enticing because they offer a way to selectively target tumors and spare most of the healthy cells in the body from attack. But, as is typical of new cancer drugs, they can also be expensive. The wholesale acquisition cost of Pluvicto will be $42,500 a dose, Novartis said in an emailed statement.

Patients taking Pluvicto will receive a maximum of six doses, administered six weeks apart, and the actual cost for patients will depend on their insurance. Novartis said it’s optimistic that most payers will cover the therapy and emphasized that it had taken a “thoughtful approach” to pricing, weighing the drug’s innovative potential, the benefits for patients and the need to ensure access to treatment.

Novartis has already had success with another radiopharmaceutical developed by Advanced Accelerator Applications. The drug, Lutathera, is approved to treat certain digestive tract cancers and had sales of $115 million in the fourth quarter of 2021.

The FDA cleared Pluvicto for patients with metastatic castration-resistant prostate cancer who have already received chemotherapy and hormone-blocking treatments. Patients’ cancer cells must also express a protein called prostate-specific membrane antigen (PSMA), which can be found on the PET scan with Novartis’s new Locametz diagnostic kit.

Pluvicto combines a radioactive particle with a targeting compound known as a ligand. The ligand seeks out tumors expressing PSMA and then the radioisotope works to either kill cancer cells or damage them enough that they can’t replicate.

PSMA is generally not expressed at high levels on healthy cells, though there are some exceptions that may explain the higher rate of side effects for patients receiving Pluvicto. About 43% of patients on the therapy suffered from fatigue, 39% from dry mouth, 35% from nausea and 32% from anemia, Novartis said. Decreased appetite affected about one in five patients, as did constipation.

Novartis will individually produce Pluvicto in special facilities and ship it on demand for patients. The company said the therapy can be given by infusion in an outpatient setting.

Bayer and AstraZeneca, meanwhile, are also developing drugs that use radioisotopes. Bayer recently acquired two small biotechs to obtain a drug that, like Pluvicto, targets PSMA.