The world of cancer treatment is constantly evolving, and new breakthroughs are often met with excitement, hope, and the promise of better outcomes for patients. One such breakthrough is the PSMA-targeted radionuclide therapy, Lu177 vipivotide tetraxetan, also known as Pluvicto. This promising treatment option has shown great potential for patients with metastatic castration-resistant prostate cancer, but unfortunately, a national shortage has prevented many from accessing this life-changing medication.
Dr. Roby Thomas, a medical oncologist and hematologist at UPMC Hillman Cancer Center, has seen firsthand the impact of this shortage on patients. In an interview, he discussed the excitement that surrounded the introduction of PSMA therapy to the treatment landscape, as well as the disappointment and frustration caused by the subsequent shortage.
“For prostate cancer, it’s one of those things where we have the VISION study demonstrating the utility of Pluvicto in a highly refractory setting,” Dr. Thomas explained. “There were high response rates, which is very promising for patients who have had multiple lines of therapy, including chemotherapy. This national shortage is another example of having some throughput, and it was getting exciting, patients were getting this life-changing medication at our institutions. But now, this has all come to a screeching halt.”
The shortage has created waiting lists for patients who desperately need the treatment, and for some, time is running out. As Dr. Thomas noted, having to tell patients that the medication they need is simply not available is heartbreaking.
“As a clinician, you do your best, but, you know, it’s hard to have those conversations with patients that, [for example], hey, we don’t have this treatment. It’s been a very promising high response rate, durable response rate, but, unfortunately, the main issue is that we just don’t have it here. And to have to say, we might be able to get it in Europe, or go to Australia or New Zealand, that’s just not something that you’d think you would be saying to somebody in the United States of America. So, it’s been a challenge. It’s definitely one that we do our best to work around, but at the end of the day, it’s just it’s, it’s not really acceptable.”
The shortage of Pluvicto is not only frustrating for patients and their healthcare providers, but it also underscores a larger problem with drug shortages in the United States. According to a report from the US Food and Drug Administration (FDA), drug shortages have been on the rise in recent years, with a record high of 282 shortages reported in 2019. These shortages can have devastating consequences for patients, as well as for the healthcare providers who are trying to care for them.
The reasons for drug shortages are varied and complex, but they often stem from manufacturing issues, regulatory problems, and supply chain disruptions. In the case of Pluvicto, the shortage is believed to be related to manufacturing issues, as the drug is produced in limited quantities by a single manufacturer.
It’s important to note that drug shortages are not unique to the United States, and they affect countries around the world. However, there are steps that can be taken to mitigate the impact of these shortages and ensure that patients have access to the medications they need.
One potential solution is to develop redundancy in the drug supply chain, which would involve having multiple manufacturers producing the same medication. This would reduce the risk of shortages caused by manufacturing issues at a single facility. Additionally, improving communication and coordination between manufacturers, regulators, and healthcare providers could help to identify potential shortages earlier and allow for more effective planning and mitigation strategies.
In the meantime, healthcare providers like Dr. Thomas are left to do their best for their patients, navigating the challenges of a drug shortage that is preventing some from accessing a potentially life-saving therapy.
“Ultimately, our goal is to provide the best care that we can for our patients,” Dr. Thomas said. “But when we’re facing a shortage like this, it creates a lot of stress, anxiety, and even despair for patients, and it’s frustrating for us as clinicians as well. We’re always looking for ways to improve patient care, and having access to these innovative therapies is a big part of that. So, it’s important that we continue to work towards solutions that can ensure that patients have the medications they need, when they need them.”
