Drug used to treat advanced prostate cancer in short supply, Novartis says
Pluvicto, a drug used to treat advanced prostate cancer, is in short supply. Department of Food and Drugs reported last week.
Novartis, the pharmaceutical company that makes Pluvicto, explained the reasons behind the supply issues In a letter Posted by the FDA last month.
In the letter, the company said it currently manufactures Pluvicto in Italy only in “small batches” and is awaiting FDA approval of a new manufacturing site. Novartis said the approval was expected to come in four to six months.
“We are running our production site at full capacity to treat as many patients as possible as quickly as possible.” said the company. “However, with a nuclear medicine like Pluvicto, there is no back-up supply to allow us to experience delays.”
Novartis said any problems caused by weather or “unplanned manufacturing events” could cause delays. The company noted that there is only a “five-day window” for the drug to reach the patient once it is ready.
The letter states that when Plocto is delayed in delivery, or has to be remade, it creates a domino effect.
The company 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 is “clear on FDA approval” of its new manufacturing facility.
Company spokeswoman Julie Maso said 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 generate as much supply as possible,” he told the Journal.
FDA Approved Plocto as a prostate cancer treatment in March of 2022.
According to numbers from American Cancer SocietyAside from skin cancer, prostate cancer is the most common cancer among American men, and approximately one in eight men will be diagnosed with prostate cancer during their lifetime.
Most men diagnosed with prostate cancer do not die from the disease, the organization said.