By JAY T. RIPTON
Not to sound too alarmist, but the radiopharmaceutical industry is on the verge of an explosion. But don’t worry; it’s not the type of explosion one often associates with nuclear materials… I love those movies too! It’s the beginning of a new wave of innovation for the diagnosis and treatment of certain cancers and other diseases.
This new radiopharmaceutical boom quite literally has the life sciences industry in a nuclear arms race of sorts, as companies like Y-mAbs, Novartis and others are pushing through clinical trials for the next blockbuster for the treatment and detection of hard-to-treat diseases like medulloblastoma and metastatic castration-resistant prostate cancer. But all this excitement has many wondering, “what are radiopharmaceuticals anyway?”
Radiopharmaceuticals are simply a group of pharmaceutical drugs containing radioactive isotopes. They are being used primarily for the treatment and detection of certain types of cancers, but they are also being developed for cardiac disease as well. And what makes radiopharmaceuticals so unique is that they can be targeted to extremely precise areas in the human body.
Although gaining ground with more precision today, this type of therapy actually began in the 1940s with I-131 – which has become an important agent for the treatment of benign and malignant thyroid disease. The development of radiolabeled antibodies began in the 1970s, and Radium-223 dichloride was approved by the FDA in 2013 for the treatment of castrate-resistant metastatic prostate cancer. Lu-177 PSMA is one of several recent developments that are making their way through FDA approvals.
“The radiopharmaceutical industry has actually been around for some time, but today it is at a tipping point,” says SpectonRx president Anwer Rizvi. “Over the next few years, it is estimated that our industry will triple. With more radiopharmaceuticals making their way through clinical trials and FDA approval, we are starting to see more data that highlight their effectiveness. This is why we are now starting to see more life sciences organizations committing real resources to radiopharmaceuticals.”
SpectronRx is a contract radiopharmaceutical development and manufacturing organization (cRDMO) that has experienced significant growth recently through partnerships with pharmaceutical and diagnostics companies globally. Rizvi’s roots within the industry go back nearly three decades, so he understands the industry inside and out. This is a must in an industry that deals with different types of radioisotopes.
Companies like SpectronRx and Cardinal Health are recognized leaders in the space, and things are about to get much busier for them. Industry experts predict that 30% of nuclear medicine procedures in 2030 will be radiopharmaceutical therapies. Lu-177 PSMA, a therapy that is growing in popularity, is being used in Germany and Australia – and it is expected to get approval within the US in the near future. There will be a huge demand for Lu-177, as there are currently more than 21 Lu-177 labeled drugs in the clinical stage.
Late last year, Y-mAbs Therapeutics announced that the U.S. Food and Drug Administration cleared the Company’s Investigational New Drug (“IND”) application for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children. And more recently, Novartis’ compound for metastatic castration-resistant prostate cancer patients had its likelihood of approval because the targeted radioligand therapy met its coprimary endpoints.
The design of these different compounds is based 100% on the physiological function of the target organ. Unlike earlier processes, which depended on tissue density differences, external imaging of radiopharmaceuticals is independent of the density of the target organ. The localization of a radiopharmaceutical in a specific target organ can be as simple as the physical trapping of particles or as sophisticated as an antigen-antibody reaction.
Because they can both treat and diagnose, many refer to these compounds as theranostic radiopharmaceuticals. Theranostic and radiopharmaceutical are often used interchangeably, but it’s all a subset of nuclear medicine.
In a recent interview, Cardinal Health Nuclear & Precision Health Solutions President Tiffany Olson explained, “Very simply put, theranostics is a therapeutic, which means ‘help fix me,’ and a diagnostic, which is ‘tell me what’s wrong. Theranostics combines those—a diagnostic and a therapeutic—for an individual and goes down to the cellular level, so patients get exactly what they need. It’s an incredibly precise way to treat different diseases.”
For traditional life sciences companies, working in the radiopharmaceutical industry isn’t an easy task. Handling radioisotopes requires standards, oversights and licensing that traditional pharmaceutical companies are not familiar with. Not just anyone or any facility can source, ship and work with radioisotopes. The environment in which we operate requires equipment validation and maintenance, SOPs, training, FDA filings and licensing that is truly unique.
“We help fill the gaps for traditional life sciences companies by providing early-stage services ranging from pre-formulation studies to formulation development and pre-clinical testing, and we can scale all the way through commercialization/full production, technology transfer and chemical and radioactive waste management,” added Rizvi. “Our facilities are FDA and NRC inspected, and we are a registered nuclear pharmacy with multiple cleanrooms, shielded isolators and hot cells. We handle all the necessary logistical and compliance matters, and FDA filing necessary for our life sciences partners.”
Another big reason for the sudden growth in the radiopharmaceutical research, development and manufacturing space is that a solid pipeline of diagnostic and therapeutic compounds is a must. Treatments have to be readily available to patients because the half-life of some radioisotopes is rather short – especially when compared to traditional compounds. This makes proximity to patients a key strategy for life sciences companies. As cancer treatment and life sciences organizations continue to make more and more headlines, it’s important to understand what the latest developments are all about. Whether you’re a patient, healthcare professional or support person, knowing the latest treatments and procedures just might make a huge difference in someone’s life. That’s why adding “radiopharmaceutical” to your vocabulary is so important. Besides, who doesn’t like a little nuclear science…
Jay T. Ripton is a freelance healthcare, technology and lifestyle writer out of Scottsdale.
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