© 2023 MJH Life Sciences™ and CURE - Oncology & Cancer News for Patients & Caregivers. All rights reserved.
A prostate cancer expert lends insight to the nationwide Pluvicto shortage, and what eligible patients can do.
Last year, the Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for the treatment of metastatic castration-resistant prostate cancer, though now, patients with the disease may not be able to get the drug due to a supply chain issues and a nationwide shortage of the therapy.
In a February 2023 statement, Novartis, the manufacturer of the radiopharmaceutical drug, explained that Pluvicto is made in small batches in Italy. Once created, the medicine must be delivered to the patient within 5 days.
“Any interruption in the process — either caused by unplanned manufacturing events, weather-related shipping delays or the challenges associated with importing a nuclear medicine into the U.S. — can result in doses not arriving in time. When that happens, impacted doses must be rescheduled and remade, causing the need to also reschedule other patient doses behind them,” the statement read, noting that since Pluvicto is a nuclear medicine involving radioactive substances, there is no backup supply of the drug, either.
To combat the shortage, Novartis filed for an FDA approval that would allow one of their New Jersey manufacturing facilities to make and distribute the drug, which, according to the company, can begin supplying Pluvico by this summer. Novartis is also building another facility in Indianapolis. These two facilities combined will hopefully be able to create approximately 250,000 doses of Pluvicto per year, starting in 2024.
“The FDA approval of the new facility in Millburn, New Jersey, will be instrumental in ensuring a stable source of the drug for patients in the United States,” Dr. Adeel Kaiser, a radiation oncologist with Baptist Health Miami Cancer Institute, said in an interview with CURE®.
But for now, Kaiser said that no new patients are being prescribed Pluvicto until the shortage is over. Those who have already been taking Pluvicto should continue to be able to do so, as Novartis announced that their priority is patients who have already received their first doses and are in the treatment process.
“Patients already on Pluvicto therapy should meet with their physician, since the shortage may result in the need to reschedule their currently planned doses. However, they should be reassured that Novartis has committed to providing the drug to complete their course,” he said.
Individuals who have not yet started Pluvicto should continue on their current treatment regimen, Kaiser said, highlighting that since Pluvicto is not used as the first medication people with the disease take, all eligible patients should have already undergone one or more prior treatment regimens.
For patients whose disease did not respond or stopped responding to all other treatment options, communicating with their health care team is key.
“(Until the shortage is resolved), they should speak to their personal oncologist if they are concerned, particularly if they have exhausted all approved therapeutic options,” Kaiser said. “Such patients may benefit from enrollment in clinical trials of other novel therapies. They may also benefit from focal therapies such as external radiation treatment if certain cancer deposits are not responding to their current drug regimen. This decision should be guided by their oncologist.”
Looking ahead, Novartis announced that they are hoping to increase Pluvicto supply to the United States within the next 12 months.
“In the meantime,” the pharmaceutical company announced, “we are committed to continuing these updates as we work to meet the high demand for this medicine, so you and your health care providers can make the best treatment decision.”
For more news on cancer updates, research and education, don’t forget to subscribe to CURE®’s newsletters here.