Supply of the cancer drug Pluvicto should increase “meaningfully” in the second half of the year, the drug’s manufacturer Novartis said Tuesday amid widespread shortages.
Pluvicto, a drug for advanced prostate cancer, started having supply problems in February as demand increased. The Food and Drug Administration listed it as being in short supply in early March.
The Swiss drugmaker said in February that it had temporarily stopped accepting new orders, leaving some prostate cancer patients out of treatment options.
Cancer drug shortage creates dire circumstances for patientsApril 12, 202303:17
The drug is made in small batches and must be given to patients within five days, making it nearly impossible to stockpile.
During a Tuesday call with investors, executives at Novartis said the drug should be more widely available around late summer to early fall as the company ramps up production at a new facility.
On Friday, the company announced that a manufacturing facility in Millburn, New Jersey, had received FDA approval to begin making the drug for commercial use in the U.S. Production will begin “in the coming weeks” and ramp up gradually, according to the company.
Novartis is also planning to ask the FDA to allow Pluvicto to be made at another manufacturing site in Indianapolis, which could also help with supply, according to slides shared by the company on the earnings call. That site could open by the end of the year, according to the company.
The drug is made for use in the U.S. at a site in Ivrea, Italy.
"Taken together, those three sites obviously have a lot of production capacity for Pluvicto," Novartis CEO Vas Narasimhan said on the call.
Pluvicto is among a handful of cancer drugs in short supply in the U.S. BCG, a drug for bladder cancer; and methotrexate and cisplatin, two common chemotherapy drugs, are also in shortage, according to the FDA. A fifth drug, fluorouracil, is also in short supply, according to the American Society of Health-System Pharmacists, a group that tracks nationwide drug shortages.
Novartis estimates it could produce at least 250,000 doses of Pluvicto annually by 2024, according to slides shared by the company.
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