Major cancer centers, including Mayo Clinic and MD Anderson, are expanding theranostics programs, which use one radioactive drug to find tumors on a scan and a matched radioactive drug to treat them, Modern Healthcare reported. The growth follows a string of FDA decisions that have made more patients eligible for these treatments.
For patients, the key point is that theranostics is not a general cancer therapy. FDA-approved uses cover a limited set of cancers, mainly advanced prostate cancer, certain neuroendocrine tumors, and thyroid cancer, and approved radioligand treatments require a scan showing that the tumor carries the right target.
That makes location and eligibility practical concerns. The drugs are radioactive, made to order, and given only at licensed nuclear medicine sites, so families may need to travel to reach a program.
Which Cancers Theranostics Is Approved to Treat
Prostate cancer is the largest use. Pluvicto, or lutetium Lu-177 vipivotide tetraxetan, targets prostate-specific membrane antigen (PSMA), a protein found on most prostate cancer cells. The FDA first approved it in 2022 for metastatic castration-resistant prostate cancer after hormone therapy and chemotherapy. In March 2025, the agency expanded its use to before chemotherapy for patients already treated with a newer hormone drug.
The label moved earlier again this summer. On July 31, the FDA approved Pluvicto with hormone therapy for PSMA-positive metastatic prostate cancer that still responds to hormone treatment, with patients selected through a PSMA PET scan.
Neuroendocrine tumors are the second major category. Lutathera, or lutetium Lu-177 dotatate, was approved in 2018 for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, which start in the digestive tract or pancreas. In April 2024, it became the first radiopharmaceutical approved for children 12 and older with these tumors. On September 14, Curium announced FDA approval of Bexlutry, a second lutetium dotatate product that Fierce Pharma described as the first radioligand equivalent of Lutathera.
Thyroid cancer has the longest history. Radioactive iodine has been used for decades, and MD Anderson lists thyroid cancer, prostate cancer, and neuroendocrine tumors among the cancers it treats with theranostics, while other uses are being studied in clinical trials.
Health Systems Race to Build Capacity
The expansion reflects both demand and research. In July, Mayo Clinic and GE HealthCare announced the MI-BET study, which will test whether imaging and blood markers can guide how many radioligand treatment cycles patients with advanced prostate cancer need, rather than using a preset number.
"Theranostics, and studies such as MI-BET, give us an important opportunity to rethink how and when we treat cancer," said Dr. Geoffrey Johnson, chair of the Radiopharmaceutical Trial Team at Mayo Clinic Comprehensive Cancer Center.
The treatment itself is usually outpatient. According to MD Anderson, patients first receive a diagnostic tracer and scan. If the tumor shows the target, they later receive a stronger treatment dose through an IV, typically without an overnight stay or anesthesia. The care team reviews the scan results before deciding whether theranostics or another treatment is the better fit.
Building a program is complex. Hospitals need nuclear medicine physicians, radiation safety staff, shielded rooms, and reliable delivery of radioactive materials with short shelf lives. Billing and reimbursement can also be a hurdle for newer centers, which is one reason access is still concentrated at large academic hospitals.
Evidence, Side Effects, and Patient Access
The evidence behind approved uses comes from randomized trials, but benefits vary. In the PSMAfore trial supporting Pluvicto's 2025 expansion, an updated analysis found the drug more than doubled median radiographic progression-free survival compared with switching hormone drugs, 11.6 months versus 5.6 months, according to Novartis. That measures how long it took for cancer growth to appear on scans, not how long patients lived.
For the newest approval, the PSMAddition trial found that adding Pluvicto to standard hormone treatment reduced the risk of cancer progression or death by 28% at the primary analysis. Overall survival data were still maturing at the time of approval.
Theranostics treatments are not cures for advanced cancer, and they carry side effects. Pluvicto's common effects include dry mouth, fatigue, nausea, and anemia, and its labeled risks include radiation exposure, reduced bone marrow function, and kidney damage. Patients receive radiation safety instructions for the days after each dose, and blood counts and kidney function are checked during treatment.
Most people with cancer will not qualify for theranostics. People with prostate cancer or neuroendocrine tumors can ask their oncologist whether they have had, or need, a targeted scan such as a PSMA PET scan, whether their cancer stage fits an approved use, and where the nearest licensed treatment site is. Patients with other cancers can ask whether a theranostics clinical trial is open at a nearby center.
Cost and coverage deserve early questions. Treatments are given in a series of doses, so patients should confirm prior authorization and out-of-pocket costs before starting. Manufacturers offer patient support programs for insurance questions and financial help.
Anyone receiving radioligand therapy who develops fever, unusual bleeding or bruising, severe fatigue, or a sharp drop in urination should contact the treatment team promptly. More approvals may follow as trials test new targets, and MedicalDaily will follow new FDA decisions and how quickly access expands beyond major centers.
Key Questions Answered
What is theranostics? A cancer approach that uses a radioactive tracer to find tumors on a scan and a matched radioactive drug to deliver radiation directly to cancer cells with the same target.
Which cancers is it approved for? Mainly PSMA-positive metastatic prostate cancer, somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, and thyroid cancer treated with radioactive iodine.
Can children receive theranostics? Lutathera is approved for patients 12 and older with certain neuroendocrine tumors.
How do I know if I qualify? Eligibility depends on cancer type, stage, prior treatment, and a targeted scan showing that the tumor carries the right marker. Ask your oncologist.
Is it a cure? No. Approved treatments can delay cancer growth and, in some settings, extend survival, but they are not cures for advanced cancer.
Where is it available? Only at licensed nuclear medicine sites, often large cancer centers, though more hospitals are building programs.
Published by Medicaldaily.com
