Upon its rise to notoriety spearheaded by drugs like Novartis’ Pluvicto (lutetium Lu 177 vipivotide tetraxetan), the radiopharmaceutical field is capturing the attention of both industry and investors, as the cancer treatment paradigm increasingly shifts towards targeted combination approaches with stronger efficacy and tolerability than traditional chemo- and radiotherapy-based regimens.
Big pharma’s intrigue into the drug class is evidence by several recent, high-profile radiopharmaceutical-focused deals in the space, with players like Eli Lilly, AstraZeneca and Bristol Myers Squibb (BMS) all seeking a slice of the maturing market through recent acquisitions.
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Companies in the radiopharmaceutical space have had a positive start to the year deal-wise, with the number of partnerships and licensing agreements inked in the first quarter of 2026 reaching 3.5-time higher values than the same period in 2025, according to GlobalData’s Pharmaceutical Intelligence Center.
As the segment gains momentum, many attendees at the 2025 American Society of Clinical Oncology (ASCO) conference, which ran from 29 May to 1 June, were keen to dive into the potential of radiopharmaceuticals in oncology. During the conference, there were multiple sessions dedicated to radioligand therapies (RLTs) – a stark contrast from the one abstract featuring a radiopharmaceutical a decade ago at ASCO 2016.
While radiopharmaceuticals continue to generate a buzz, experts note that several steps will need to be taken for the drug class to hit the mainstream in cancer care.
Alpha emitters may hit the prime time
As he took in the atmosphere on the ground at ASCO, Andy Hsieh, biotech equity research analyst at William Blair, was keen to follow the radiopharmaceutical developments from the conference, given his keen focus on the drug class through his coverage.
On the show floor, Hsieh recalls hearing chatter about whether high-potency, short-range alpha-emitting therapies have yet to reach their prime, as beta-emitting versions like Pluvicto and Novartis’ Lutathera (lutetium Lu 177 dotatate) with longer-range radioactivity currently dominate the commercial landscape.
In Hsieh’s view, the short answer is yes.
However, he stresses the importance of being “mindful around the placement of alpha emitters compared to beta therapies”, given the potency and corresponding safety profile of the former. This, Hsieh says, requires drug sponsors to “think carefully about the benefit-risk ratio for patients as they position alpha emitter-based therapies earlier in the treatment paradigm”.
Jefferies senior equity research analyst, Andrew Tsai, sees potential in actinium and lead-based alpha-emitting therapies, noting that data from Novartis’ Phase I AcTION trial (NCT04597411), on actinium-based RLT, 225Ac-PSMA-617, in men with metastatic castration-resistant prostate cancer (mCRPC) presented at ASCO 2026 were “quite encouraging”. Tsai adds that clinicians he has spoken to are also enthusiastic about the alpha modality due to its potential to provide better efficacy and a cleaner safety profile – though he himself is not fully sold on this based on the data he’s seen thus far.
“I’m encouraged, but alpha and beta therapies each have their pros and cons,” Tsai comments. “Novartis has established a smooth supply chain for Pluvicto, and that’s something that needs to be thought about for the alpha class.”
The conjugate debate continues
Alongside the alpha versus beta discourse, Hsieh heard a lot of discussions around which targeting molecule may come out on top in the radiopharmaceutical space, as companies branch out their approaches by developing antibody, small molecule and peptide-based therapeutics. Each of these molecules come with their own perks and drawbacks, both analysts note.
According to Tsai, the safety of small molecule RLTs is standing out a little more at this early stage, as antibody-based approaches have previously been associated with elevated cases of adverse events (AEs) like cytopenia. Hsieh echoes Tsai’s sentiments but notes that their targeting specificity could potentially offer them an edge, despite their weaker ability to penetrate deep into the tumour microenvironment.
Hsieh adds that antibody and small molecule-based radiopharmaceuticals have very different half-lives, which result in their own distinct AEs – something that developers would benefit from considering when designing their RLT.
As the field progresses, Tsai believes that there isn’t just going to be one or two dominant players in the radiopharmaceutical niche, referring to isotopes and differing modalities. “Ultimately, I think multiple players can win; that’s my big picture view,” he says.
On-target AEs remain a hurdle
Though Hsieh remains bullish on the future potential of radiopharmaceuticals within oncology, he does raise some concerns around “on-target, off-tumour” AEs observed in patients with prostate cancer. These issues came into sharp focus during a session covering the Phase I AcTION trial at ASCO 2026, as a high proportion of patients experienced dry mouth that didn’t recover with time – primarily due to the buildup of radiation within the salivary glands, which also produce the target antigen, PSMA.
“Dry mouth can be a huge impediment when it comes to quality of life. In the AcTION trial, some patients lost weight because they lost their ability to salivate, which makes it hard to eat; the irreversibility makes it really tough,” Hsieh adds.
This event has caused some reservations amongst analysts. “We have to be very careful when it comes to frontline, thinking about these longer-term, irreversible impacts on QoL,” Hsieh comments.
From the current data, Hsieh notes that dry mouth issues appear to be slightly less prevalent on the antibody front compared with small molecule alternatives, though this trend will need to be studied further.
Accessibility poses as potential innovation roadblock
As the radiopharmaceutical drug class gathers steam in oncology, Harpreet Singh, former director of oncology at the US Food and Drug Administration and CMO at Precision for Medicine, points out the age-old mantra haunting the industry: ‘approval doesn’t equal access’.
When building an accessibility infrastructure for RLTs, Singh notes that companies must establish a strong and resilient isotope supply chain, secure reimbursement and find sites with the capacity and workforce to administer such therapies – all of which can prove challenging to achieve.
If RLTs aren’t widely accessible, Singh warns this could have knock-on effects downstream to companies ushering in the next generation of RLTs, as fragmented access to already approved therapies in the drug class could complicate the regulatory and technical picture for emerging players.
“Take the classic example of Pluvicto. When the next company wants to develop an asset in prostate cancer, the control arm will likely have to include Pluvicto when running trials in this disease,” Singh comments.
As prostate cancer trials tend to enrol more than 1,000 patients situated across the world, Singh notes that issues around global access could force companies to make trial design modifications. This could include employing an investigator’s choice comparator arm, where Pluvicto is part of the choice, but not required – a move that she describes as “less than ideal for the FDA”, which wants to see a data package it believes is reflective of the US population.
“It’s not the FDA’s purview to grant access, and if people don’t have access to the best available option, it can jeopardise the regulatory and technical strategy for emerging assets,” Singh says. This could potentially impact patient access to the next transformative therapy, as it may not be possible to study the new therapy against what is already FDA approved in this case, she adds.
Tsai also emphasises the need for companies to actively prove they can scale production from clinical to commercial, which could be particularly challenging for RLTs based on short half-life isotopes like lead, requiring production close to hospitals to ensure efficacy. “In some cases, it’s almost more of an idea than something established,” Tsai concludes.
