- Novartis is working to expand production of its in-demand prostate cancer drug Pluvicto, announcing Friday it has completed an application to the Food and Drug Administration for approval of a New Jersey factory that manufactures the medicine.
- The Swiss drugmaker has struggled to produce sufficient quantities of Pluvicto since its approval last year. Manufacturing was halted in May so Novartis could address unspecified quality issues, which it said it resolved in late June. But patient demand for the therapy has remained higher than Novartis expected, particularly after positive clinical trial results announced in December.
- Pluvicto is what’s known as a radiopharmaceutical drug. They are complex to make, combining a radioactive isotope with a targeting compound called a ligand. Novartis expects to be able to produce 250,000 doses of it annually by next year, should it gain FDA clearance to use the New Jersey site for commercial supply.
Novartis bought Pluvicto in its $2.1 billion deal for Endocyte, part of a broader push by CEO Vas Narasimhan into radiopharmaceutical drugs. The treatment won U.S. approval last March for castration-resistant metastatic prostate cancer following treatment with androgen-blocking medicines and with chemotherapy. The more recent results in December, meanwhile, could help expand its use earlier in the treatment of prostate cancer.
The company has set high sales expectations as a result, predicting Pluvicto could eventually earn over $2 billion a year.
“From a demand standpoint, I would say our initial estimate of the [eligible] population have underestimated the potential of this population and the demand would suggest to us that there are a greater number of patients and providers interested in this medicine,” Narasimhan said on a recent earnings call.
With production falling short of demand, Novartis has limited new patients starting treatment with Pluvicto, according to Fierce Pharma.
“It's a question of us continuing to expand our capacity to meet what is a much larger interested population than we initially expected,” Narasimhan said on the call.
Should the FDA approve commercial production from the New Jersey factory, Novartis expects it could begin supplying the drug by the summer. Alongside that facility, Novartis is building another site in Indianapolis that it expects could be operational by the end of the year.