The shortage of a drug approved just shy of one year ago by the FDA to treat prostate cancer is now in limited supply, concerning some physicians.
Manufactured by pharmaceutical giant Novartis, Pluvicto works by delivering a therapeutic radioactive particle combined with a targeting compound to kill cancer cells. It can be used to extend the lives of patients diagnosed with metastatic castration-resistant prostate cancer.
Novartis has said the shortage is "from manufacturing and delivery issues," according to The Wall Street Journal. Availability of the supply will be prioritized for patients who have already started the six-course regimen of the drug.
Concerns surround the fact that the drug is currently "the only treatment of its kind available," and without it patients will have to turn back to standard treatments like alternative chemotherapy.
Even with Novatis working to address the shortage, the meantime could be deadly for those who are waiting for the resupply.
"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 Wall Street Journal. "The treatment isn't a cure, but it does extend patients' lives."
One of the challenges is that the drug is currently only manufactured in Italy and that facility is already operating at full capacity, according to Julie Masow, a spokesperson for Novartis. Once developed, the drugs must be given to patients within five days' time — so any disruption in that time frame can make things take a turn for the worse. However, the company did file a request to manufacture it in the U.S. at its New Jersey facility, The Wall Street Journal reported.
"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," Ms. Masow told The Wall Street Journal.