Novartis' Prostate Cancer Therapy Hit By Supply Crunch, Seeks To Ramp Up Production To Ease Supply Issues
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Last week the FDA said Novartis AG's (NYSE: NVS) Pluvicto is short in supply due to manufacturing and delivery issues.
Pluvicto is a radiopharmaceutical medication used for prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer.
FDA approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) in march last year, the first targeted radioligand therapy for prostate cancer.
Novartis said it is prioritizing the supply for patients who have already started the six-course regimen as it manages the shortage.
Novartis is also "taking the difficult but necessary step" of halting the addition of new patients for the treatment as they try to increase supply, Wall Street Journal noted, citing spokeswoman Julie Masow.
"Our ability to supply Pluvicto with only one approved site is presenting significant challenges, and we are working around the clock to generate as much supply as possible," Mascow said.
Pluvicto is manufactured at a facility in Ivrea, Italy. It is produced in small batches and must be given to each patient within five days.
Novartis said it is operating the Italy facility at full capacity. It filed last month for FDA approval to manufacture commercial Pluvicto for patients in the U.S. at its site in Millburn, N.J. The company has asked the agency to expedite its review, Ms. Masow said.
The company said it wouldn't take new orders for Pluvicto until it had clarity on the approval of more production capacity, which is expected in four to six months.
Price Action: NVS shares are up 0.63% at $82.62 during the premarket session on the last check Thursday.
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This article Novartis' Prostate Cancer Therapy Hit By Supply Crunch, Seeks To Ramp Up Production To Ease Supply Issues originally appeared on Benzinga.com
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