Natalia Chi
Pullvict, a treatment for advanced prostate cancer, is in short supply. Food and Drug Administration reported last week.
Novartis, the pharmaceutical company that makes Pluvicto, has outlined the causes behind the supply problem. by letter FDA announced last month.
In the letter, the company said it currently manufactures Plurvict only in “small batches” in Italy and is awaiting FDA approval at its new manufacturing facility. According to Novartis, the approval was due in four to six months.
“We are running our production facility at full capacity to treat as many patients as possible as quickly as possible,” the company said. “But nuclear medicine like Pluvicto doesn’t have a backup supply available in case of delays.”
Novartis said problems caused by weather and “unplanned manufacturing events” could cause delays. He said there was no choice.
The letter points out that there will be a domino effect if Pluvicto ships late or needs to be reworked.
The company said it is currently prioritizing “patients who have received their first dose and are currently on treatment.”
Novartis said it would not accept new orders until “clear FDA approval” of its new manufacturing facility.
Company spokesperson Julie Massou said: wall street journal On Thursday, Novartis is seeking FDA approval to manufacture commercial Pullvict at its facility in Milburn, New Jersey.
“Our ability to supply Pluvicto with just one approved site presents a significant challenge, and we are working around the clock to generate as much supply as possible,” she told the Journal. told to
FDA approved Pluvicto as a treatment for prostate cancer in March 2022.
According to figures from American Cancer SocietyExcluding skin cancer, prostate cancer is the most common cancer in American men, with approximately 1 in 8 men diagnosed with prostate cancer during their lifetime.
Most men diagnosed with prostate cancer will not die from the disease, the organization says.
Trevorne Howard
