Dive Brief:
- Novartis’ radiopharmaceutical drug Pluvicto can now be used much more widely to treat men with a type of metastatic prostate cancer after U.S. regulators on Friday cleared the medicine for use before chemotherapy.
- Specifically, Pluvicto can now be given to patients following initial treatment with a type of hormonal drug known as androgen receptor pathway inhibitors. Only individuals whose tumors are considered castration resistant and express a protein called PSMA are eligible for treatment.
- In late-stage testing, Pluvicto reduced the risk of disease progression or death by 59% compared to switching patients onto another “ARPI” drug. However, an analysis of overall survival did not find a difference between the two groups, although Novartis said this was due to many patients in the control arm “crossing over” to receive Pluvicto.
Dive Insight:
Pluvicto, a drug Novartis gained by acquiring the biotechnology company Endocyte six years ago, is one of the pharma giant’s priority products. Known as a radiopharmaceutical, it links a cancer-killing radioisotope to a targeting molecule designed to home in on the PSMA protein that’s found on prostate tumors.
Beyond boosting Novartis, the success of Pluvicto has lifted the broader field of radiopharmaceutical drug research, which has drawn in other large drugmakers like Bristol Myers Squibb, Eli Lilly, AstraZeneca and Sanofi. Smaller biotechs and newer startups are also benefiting from the boom.
However, radiopharmaceuticals are difficult to produce and delivering them requires a precise choreography to ensure the radioisotope they contain doesn’t decay to a point treatment is ineffective.
Even Novartis, a company that’s mastered complex therapies like CAR-T cell therapy, has struggled on this point. In May 2022, it had to suspend production of Pluvicto at certain plants to fix issues in the drug’s manufacturing.
Those have since been fixed and last September, Novartis announced plans to expand a factory in Indianapolis and build a new plant in California. The company said it can “fully meet supply needs” to support the expand approval, which triples the number of prostate cancer patients who are eligible for treatment. Delivery can be made to almost 600 treatment sites in the U.S., usually within five days, Novartis said.
In the Phase 3 study supporting Pluvicto’s new indication, more than 60% of patients in the ARPI arm went on to receive Novartis’ drug, muddying the survival comparison between the two groups.
Novartis ran another analysis that uses statistical assumptions and weighting to adjust for that crossover. According to that data, which as an after-the-fact analysis is considered less conclusive evidence, the relative reduction in the risk of death was 41%, Novartis said. (Unadjusted, the risk reduction was measured at 9% versus switching to another ARPI.)
Sales of Pluvicto reached nearly $1.4 billion, and Novartis expects the expanded approval will lift those even higher — to more than $5 billion annually over time. The company has recently started advertising Pluvicto on TV as well.
