Pluvicto, a drug used to treat advanced prostate cancer, is in short supply, the Food and Drug Administration reported last week.
Novartis, the pharmaceutical company that makes Pluvicto, outlined the reasons behind the supply problems in a letter posted by the FDA last month.
In the letter, the company said it currently manufactures only “small batches” of Pluvicto in Italy and is awaiting FDA approval at a new manufacturing site. That approval is expected to come in four to six months, Novartis said.
“We are operating our manufacturing site at full capacity to treat patients as quickly as possible.” The company said. “However, with nuclear drugs like Pluvicto, there is no back-up supply that we can draw from when we experience a delay.”
Novartis said any problems caused by weather or “unplanned production events” could cause delays. The company noted that there is only a “five-day window” for the drug to reach the patient after it is manufactured.
When Pluvicto’s shipment is delayed, or it has to be redone, it creates a domino effect, the letter noted.
The agency said it is currently “prioritizing patients who have received their first dose and are currently undergoing treatment.”
Novartis said it will not take any new orders until it has “clarity on FDA approval” of its new manufacturing facility.
Company spokeswoman Julie Maso told The Wall Street Journal on Thursday that Novartis is seeking FDA approval to manufacture commercial Pluvicto at its site in Millburn, New Jersey.
“Our ability to supply Pluvicto with only one approved site presents significant challenges, and we are working around the clock to build as much supply as possible,” he told the Journal.
The FDA approved Pluvicto as a prostate cancer treatment in March 2022.
Besides skin cancer, prostate cancer is the most common cancer in American men, and about one in eight men will develop prostate cancer in their lifetime, according to the American Cancer Society.
Most men diagnosed with prostate cancer do not die of the disease, the agency said.