When shipments of Pluvicto are delayed, or it has have to be remade, it creates a domino effect, the letter noted. The company noted there is only a "five-day window" for the drug to reach the patient once its manufactured. Novartis said that any issues caused by weather or "unplanned manufacturing events" can cause delays. "However, with a nuclear medicine like Pluvicto, there is no back-up supply that we can draw from when we experience a delay." "We are operating our production site at full capacity to treat as many patients as possible, as quickly as possible." the company said. That approval was expected to come in four to six months, Novartis said. In the letter, the company said that it currently only manufactures Pluvicto in Italy in "small batches," and is awaiting FDA approval on a new manufacturing site. Novartis, the pharmaceutical company that manufactures Pluvicto, outlined the causes behind the supply issues in a letter posted by the FDA last month.
Pluvicto, a drug used to treat advanced prostate cancer, is in short supply, the Food and Drug Administration reported last week.
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