Four anticancer drugs are facing supply shortages, according to the FDA.
Among these is Pluvicto, a drug to treat advanced prostate cancer with radiation.
For patients who rely on Pluvicto, physicians should discuss how the shortage is impacting prescriptions and evaluate alternative medications on a case-by-case basis.
Several cancer-fighting drugs are facing supply shortages, forcing some patients to forgo essential care or lean into alternative therapies. Among these drugs is Pluvicto, a drug that uses radiation technology to treat advanced prostate cancer.
What makes Pluvicto so important?
Pluvicto is a radioligand drug used to treat metastatic or advanced prostate cancer. It works by delivering radiation to the prostate cancer cells with the intent of killing them.
According to S. Adam Ramin, MD, medical director of Urology Cancer Specialists in Los Angeles and expert in surgical treatment of prostate cancer, the drug is designed to recognize the prostate-specific membrane antigen (PSMA) membrane (a surface protein which is also looked at during PET scans for prostate cancer) which allows it to target the cancer cells. This doesn’t mean the design is flawless, however, and other cells can sometimes be impacted by the drug, too, he adds.
The concept of “targeted delivery” has been new to medicine within the last 15 to 20 years, and tends to produce fewer side effects than other types of drugs—which is part of what marks Pluvicto such an important tool in fighting cancer, says Ramin. Further, Pluvicto has been approved for patients who have not found success with other medications.
“This is a medication that's been approved for patients who have been treated with other forms of therapy and have essentially reached a point where the other forms have failed, or they're not working as well,” says Ramin.”It's one of those therapies that is needed for patients who have no other recourse.”
What’s causing drug shortages?
Multiple factors may be responsible for the shortage of anticancer drugs and drugs in general. Ramin credits some shortages to labor issues stemming from the pandemic's beginning.
“Unfortunately, this issue is not specific to this drug,” says Ramin. “There is a relative shortage of various supplies in medicine. Since COVID started, one of the issues is that most of these radioisotopes or radioactive materials have become short in supply.”
Some doctors have also suggested that companies may be less inclined to replenish the supply of generic drugs, which are less profitable for drug makers, according to NBC News.
In addition to Pluvicto, the Food and Drug Administration (FDA) has listed three other anticancer drugs as under shortage. These include BCG, a drug that treats bladder cancer, and cisplatin and methotrexate, two drugs used for chemotherapy.
For Pluvicto, delayed shipments are unusable
Fixing the anticancer drug supply issue requires a multifaceted approach—identifying and addressing gaps in product manufacturing and shipments. Particularly for drugs that use radiation, shipment delays can deem the product ineffective, putting efforts to vamp up production to waste.
“This drug deals with radioactivity, and any radioactive material has a degradation rate, which means that over time, the radioactivity degrades and becomes innocuous—becomes inactive,” says Ramin.
According to Novartis, Pluvicto’s manufacturer, Pluvicto is made in small batches in Italy and has a five-day window to reach its patient.
“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 US—can result in doses not arriving in time,” the company wrote in a release in February. “When that happens, impacted doses must be rescheduled and remade, causing the need to also reschedule other patient doses behind them.”
This also means that Pluvicto does not have a “backup supply” to pull from when shortages occur, the company added.
How is Novartis addressing supply issues?
According to Novartis, the company is working to “significantly increase Pluvicto supply over the next 12 months” and will do this by adding two new manufacturing sites based in the US. They will need FDA approval for the new sites, which could take around six months to receive. In the meantime, the company says they will not be taking new orders of Pluvicto but will be working to replenish the supply for patients who have already started the therapy.
“Our priority is to supply those patients who have received their first doses and are currently in the treatment process,” the company said in their release. “As we endeavor to provide patients who have received one or more doses with their full treatment course, patients who are currently in our scheduling system and awaiting their first doses will need to be rescheduled. We are striving to serve as many patients as possible as quickly as possible as we work through the current situation.”
The company will be reaching out to healthcare providers to schedule dose arrivals, according to the release.
What alternatives do patients have?
Patients left without Pluvicto or another anticancer drug in short supply may be forced to wait for treatment or try alternative medications or therapies. It’s important for providers to have individual conversations with patients about if and which medications they may be able to tolerate in the interim—and to go over patient histories to understand which other drugs have or haven’t benefited them in the past.
“If they can't get a hold of it, unfortunately, they have to try to wait. But there are some alternatives in terms of treatment, including some chemotherapies and some other types of oral medications which may help until this particular drug is available,” says Ramin. “It's important to discuss these matters and for patients to know what's going on, and hopefully, things will improve over the next few months.”
What this means for you
Some anticancer drugs like Pluvicto are facing supply chain issues, which may not be resolved for six to 12 months. For providers treating patients with these drugs, it is important to conduct transparent conversations about the issue at hand and go over feasible alternatives on a case-by-case basis.