Radiopharmaceuticals are gaining ground in oncology, combining targeted treatment with the delivery of radiation directly to tumors or tumor-associated targets. Yet approval does not guarantee that patients can receive them. Time-sensitive supply chains, limited radiopharmacy capacity, specialist workforce requirements, and uneven reimbursement pathways can all restrict access after a product reaches the market.
Here, Harpreet Singh, Chief Medical Officer at Precision for Medicine and former Division Director of Oncology at the FDA, and John McIntyre, Senior Regulatory Strategy Director at Precision for Medicine, discuss the operational constraints shaping the field, where complications arise between approval and treatment, and why implementation planning should begin during early clinical development.
How would you describe the current radiopharmaceutical landscape in oncology?
Radiopharmaceuticals have moved from a specialized area of nuclear medicine into a rapidly growing therapeutic class in oncology. Recent congresses show increasing focus on this area.
The combination of targeted therapy and radiation delivery has created a compelling treatment modality. These products deliver cytotoxic radiation to tumor cells or tumor-associated targets while limiting off-target exposure. That creates opportunities for more precise patient selection, real-time assessment of biodistribution, and, in some programs, more individualized treatment planning through dosimetry.
While still emerging, radiopharmaceuticals are now being evaluated with the same level of clinical rigor expected across oncology, including clear evidence of clinical benefit, safety, patient impact, and dose justification.
The field has tremendous momentum, but it is also infrastructure-dependent. Development success and patient access rely on infrastructure readiness, including isotope supply, radiopharmacy capacity, trained teams, site readiness, logistics and regional regulatory alignment. As a result, the landscape is scientifically validated but operationally constrained – a high-growth field where infrastructure, not biology alone, is the primary rate-limiting step.
What factors influence whether an approved radiopharmaceutical reaches the patients who may benefit from it?
Regulatory approval does not inherently translate into patient access. Several factors determine whether a patient can receive an approved radiopharmaceutical as follows:
Isotype supply and logistics. The supply chain for this modality is fragile, and these products depend on radionuclide production, radiolabeling, quality control, and time-sensitive distribution. Delivery must be coordinated within a narrow window.
Infrastructure and workforce availability. Site readiness requires licensing, infrastructure, trained personnel, and workflows for imaging, administration, monitoring, and follow-up. Availability of nuclear medicine departments, radiopharmacies, and imaging capacity is critical.
Reimbursement and economic viability. Complex coding, delays in reimbursement pathways, and uncertainty during early launch phases can discourage provider adoption. Misalignment between diagnostic and therapeutic reimbursement in theranostics further complicates access.
Regulatory and policy environment. Dual or triple oversight (drug, radiation, facility) can slow implementation and create regional variability.
What can be learned from the post-approval experiences of radiopharmaceuticals such as Pluvicto and Lutathera?
These therapies validated clinical potential and increased confidence in the field. Their post-approval experience showed how quickly infrastructure, supply, and site capacity determine real-world adoption.
For radiopharmaceuticals, delivery infrastructure and systems are as critical as the treatment itself. If isotope supply, radiopharmacy capacity, or site readiness is limited, then access can remain concentrated in certain centers or regions, even after regulatory approval.
We also saw that post-approval access can influence future development. If an approved radiopharmaceutical is considered standard of care in one region but is not available in another, that can complicate comparator selection in global trials. The control arm can impact feasibility, statistical interpretation, site participation, and global registrability.
The broader takeaway is that radiopharmaceuticals should be planned as integrated therapeutic systems, with complex needs. Developers need to connect critical operations early, ensuring supply, clinical execution, regulatory strategy, site readiness, and access planning are aligned from the start. Otherwise, demand can outpace infrastructure.
What are the main steps between approval and treatment, and where can complications arise?
After approval, several steps occur before treatment, making this pathway more complex than for conventional drugs.
Patients must first be identified and confirmed as appropriate, often via diagnostic imaging. Sites must verify licensing, radiation safety, radiopharmacy capability, trained staff, and scheduling capacity.
The product is then prepared, radiolabeled, quality-checked, shipped, received, and administered within a defined time window. Follow-up imaging, testing, and monitoring are often required.
This complex supply chain creates multiple failure points. Isotope shortages, shipment delays, limited radiopharmacy capacity, or site readiness gaps can disrupt delivery. Patients may need to travel or undergo extensive procedures, affecting access and experience.
At what stage should companies begin thinking about access, delivery, and implementation for radiopharmaceuticals?
Companies should begin thinking about access, delivery, and implementation as early as Phase 1 development. For radiopharmaceuticals, access cannot be deferred to launch planning as early development decisions can shape whether a program is operationally feasible, scalable, and suitable for global development. Sponsors need to understand from the outset whether the therapy can be reliably produced, delivered, administered, and supported across the sites and regions where development will occur.
This is especially critical for global development where a therapy may be approved or available in one region but difficult to access in another. If that variability is not anticipated early, it can impact later-stage trial feasibility, interpretation, and regulatory alignment.
Early planning also helps sponsors distinguish between sites that can administer approved radioligand therapies and sites that can support the more intensive requirements of clinical development. Early-phase radiopharmaceutical trials often require more intensive imaging, monitoring, sample handling, and radiation safety workflows than conventional oncology studies. Those requirements need to be matched to site capabilities from the beginning.
What practical steps could biopharma companies, regulators, and health systems take to support broader and more timely access in the future?
Biopharma companies can support broader access by building access-aware development plans proactively, connecting operational feasibility, patient experience, and regulatory strategy from the beginning. Sponsors should also pressure-test whether their operational model can scale from early-phase studies into later-stage, multi-regional development. Investment in logistics networks, workflow design or reimbursement guidance can all assist in improving access.
Regulators can help by providing clear, fit-for-purpose guidance and allowing flexible trial designs where access is limited. Early and ongoing dialogue is critical.
Health systems should strengthen infrastructure, workforce, imaging capacity, and care pathways, as system capacity, and not scientific demand, is often the bottleneck.
Greater coordination across stakeholders is also needed. Ultimately, radiopharmaceuticals highlight that precision medicine succeeds only when innovation is matched by operational readiness, regulatory clarity, and system capacity.
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