Novartis, FDA confirm shortage over for prostate cancer drug

The FDA declared the shortage resolved for Pluvicto, a prostate cancer drug made by Novartis.

The shortage began in the spring, sparking concern among oncologists who described Pluvicto as "the only treatment of its kind," to The Wall Street Journal in March.

"People will die from this shortage, for sure," Jonathan McConathy, MD, PhD, director of the division of molecular imaging and therapeutics at the University of Alabama at Birmingham, told the Journal in March. "The treatment isn't a cure, but it does extend patients' lives."

Issues with delivery and manufacturing propelled the shortage. The drugmaker had been pushing to begin manufacturing Pluvicto at a facility in New Jersey, which was approved by the FDA in April, and allowed Novartis to initially estimate an end to the ongoing shortage by the end of the year, but the approval allowed it to deliver ahead of schedule.

"This determination is the result of efforts to significantly scale up production of Pluvicto that have more than doubled weekly production capacity since May…" Novartis stated in an Oct. 26 press release. "Novartis currently has more than sufficient supply to treat patients within two weeks of diagnosis, which is important for these patients with advanced disease who may need treatment quickly."

In 2024, the company plans to increase production lines to create additional capacity at the New Jersey facility and at another site in Indianapolis.

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