Imaging advocacy group warns of supply shortage that’s having ‘profound negative impact’ on patient care

The Society of Nuclear Medicine and Molecular Imaging is warning of an ongoing supply shortage that’s producing a “profound negative impact” on patient care.

Scarcities of the drug Pluvicto—a radiopharmaceutical used to treat metastatic prostate cancer—are leading to delays of three months or longer for new patients. Drugmaker Novartis has said it will not accept any new patient starts until the launch of its new manufacturing facility in New Jersey. And that’s likely to take upward of six months, SNMMI said in a March 8 news update.

“SNMMI is very concerned about this situation and will work vigorously to help make lifesaving/life-prolonging radiopharmaceutical therapies available to patients in need,” the society said.

The U.S. Food and Drug Administration first greenlit the drug (and a complementary imaging agent) a year ago. Pluvicto is the first FDA-approved, targeted radioligand therapy for the disease. The agency’s blessing follows years of clinical trials. However, since the authorization, the administration has only OK’d one site to manufacture the drug.

Small batches of the drug from Ivrea, Italy, only have five days to reach patients or risk going bad.

“Any disruption in the production or shipping process can create a delay,” SNMMI said Wednesday. “If that delay extends beyond the five-day window, the dose must be destroyed and the patient rescheduled, which then has ripple effects through the waiting list and patient treatment schedule.”

SNMMI is now urging the FDA to grant expedited approval for the New Jersey facility. It’s also in contact with Novartis leaders “who are creatively investigating all options,” and working patient advocacy groups to further apply pressure on the two organizations.

Radiologists recently took to Twitter to voice their frustrations over the situation.   

Thomas Hope, MD, said his institution has had patient doses canceled for five weeks in a row by Novartis.

“Never thought production would be the limiting factor for patient access,” Hope, a nuclear medicine physician and radiologist with the University of California San Francisco, shared on Feb. 26.

“We had four treatments cancelled just this last Friday,” Very frustrating!” Nadine Mallak, MD, a radiologist and nuclear medicine expert with Oregon Health & Science University, tweeted in response on Feb. 27. “In some patients [prostate-specific antigen] rises in the interval waiting to be rescheduled, while they were initially responding well!”

Novartis issued an update about the ongoing shortage Thursday, saying it’s taking the “difficult but necessary step” to pause accepting patients until it irons out the supply issues. They hope to “significantly” increase Pluvicto production during the next 12 months, which is partially contingent on the approval and opening of the New Jersey site.

“We recognize that any rescheduled dose is distressing for patients and their loved ones and poses challenges for the treatment centers,” the company said March 9.  “We are striving to serve as many patients as possible as quickly as possible as we work through the current situation.”