Diana’s Opening Note

Two things happened this week that change the shape of PSMA practice, and they pull in opposite directions. The FDA moved Pluvicto into hormone-sensitive disease, which will push a much larger group of men toward PSMA PET. Four days later, Curium and Lantheus agreed to merge, which narrows the number of companies supplying the tracers and therapies those men will need. More demand, fewer suppliers. Both belong on the same planning agenda.

Editor’s Spotlight

The strongest signal this week is that radioligand therapy has moved earlier in the disease course at the same moment its supply base is consolidating. The FDA approved Pluvicto in combination with an androgen receptor pathway inhibitor for PSMA-positive metastatic hormone-sensitive prostate cancer, roughly doubling the eligible population, while Curium and Lantheus signed a definitive merger agreement valued at up to $8.0 billion. For practices, the implication is operational as much as clinical: PSMA PET is becoming a front-line eligibility test, and the vendors supplying it are becoming fewer.

Story of the Week

The FDA approved Pluvicto in PSMA-positive metastatic hormone-sensitive prostate cancer on July 31, in combination with an androgen receptor pathway inhibitor. The approval rests on the Phase 3 PSMAddition trial, in which the combination reduced the risk of progression or death by 28% against standard of care, and by 33% in the updated analysis with a positive overall survival trend. Pluvicto is now approved across PSMA-positive metastatic prostate cancer rather than only in the castration-resistant setting, roughly doubling the number of patients who may be eligible and moving PSMA PET from a late-line gatekeeper to a front-line eligibility test.

Clinical News

A JNM analysis of 3,709 patients across 46 French centers reported the largest real-world Lu-PSMA-617 cohort to date, drawn from France’s early-access program. Median imaging progression-free survival was 7.6 months versus 8.7 months in VISION, with disease control in 82% of patients by PSA criteria, even though the real-world population was older, more heavily pretreated, and had more lymph node metastases. Some patients with early PSA progression after the first cycle later responded, suggesting a flare effect. No new safety signals were identified.

Dosimetry from the Phase 2 RESIST-PC trial found organ absorbed doses within tolerable ranges across 48 patients, with no significant difference between the 6.0 GBq and 7.4 GBq arms. Tumor absorbed doses varied widely both between and within patients regardless of injected activity, and tumor dose correlated with PSA response — a reminder that dose delivered, not dose administered, is what tracks with benefit.

Business & Industry Intelligence

Curium and Lantheus signed a definitive merger agreement under which Curium will acquire Lantheus for $102.50 per share in cash plus contingent value rights of up to $12.00 per share tied to commercial milestones through 2030, valuing the transaction at approximately $8.0 billion. Lantheus’s board approved unanimously and closing is expected in the first half of 2027. The combination would place two of the largest PSMA imaging and radiopharmaceutical suppliers under common ownership, spanning diagnostics and therapeutics across more than 70 countries.

Curium advanced plans for a second production investment in Romania, identifying a preferred site in the Cluj-Napoca region and a preferred local partner. The added cyclotron capacity is intended to strengthen PET supply across Northern Romania and neighboring markets.

ITM introduced Lumara Bio as its new oncology therapeutics division, consolidating its pipeline and the internal teams supporting development and commercialization. The division is focused on launch readiness for 177Lu-edotreotide (ITM-11), which carries an August 28 PDUFA goal date in gastroenteropancreatic neuroendocrine tumors.

Telix will report results for the half-year ended June 30 on August 20, following second-quarter revenue of US$247 million.

Practice Insights

Model the hormone-sensitive volume shift before it arrives. The mHSPC approval turns PSMA PET from a late-line gatekeeper into a front-line eligibility test, and most programs are not currently staffed for that volume. Re-forecast scanner slots, therapy chair time, and radiopharmacy scheduling against the larger eligible population, agree referral criteria with urology and medical oncology now rather than after a backlog forms, and decide in advance what trigger justifies adding capacity.

Clinical Trials to Watch

PSMAddition — now the basis for FDA approval of Pluvicto in PSMA-positive mHSPC, with a 33% reduction in the risk of progression or death in the updated analysis.

COMPETE / ITM-11 — 177Lu-edotreotide is under FDA review in GEP-NETs with an August 28 PDUFA goal date, after the trial met its progression-free survival endpoint against everolimus.

AMPLIFY — Clarity’s Phase 3 imaging trial of 64Cu-SAR-bisPSMA in biochemical recurrence, with primary completion estimated for December 2026.

Pixclara (TLX101-Px) — Telix’s glioma PET agent carries a September 11 PDUFA goal date and holds Fast Track and Orphan Drug designations.

Industry Movers / News in Brief

Clarity’s commercial manufacturing agreement with Nucleus RadioPharma supports Cu-64 SAR-bisPSMA supply from Rochester, Minnesota, a site with capacity for roughly 50,000 patient doses a year.

ASTRO 2026 is scheduled for September 26-30 in Boston; EANM’26 for October 17-21 in Vienna; ESMO 2026 for October 23-27 in Madrid; and the SNMMI Theranostics Conference for November 4-8 in Bethesda.

Diana’s Take

The Pluvicto expansion is the bigger operational story of the two. Moving radioligand therapy into hormone-sensitive disease changes who gets scanned, how often, and how early, and most programs are not currently staffed for that volume. Plan capacity against the new indication, then look hard at supplier concentration: once Curium and Lantheus combine, a large share of both imaging and therapeutic supply sits with one counterparty. Programs relying on a single vendor for both tracer and therapy should be pricing that risk into contracts now, while there is still a competitive alternative to point to.

About the Author

Diana J. Errico is Director, Strategic Service Lines at Molecular Imaging Services. She focuses on helping healthcare organizations evaluate, implement, and grow advanced molecular imaging, PET/CT, PSMA PET, and theranostics programs through strategic planning, clinical workflow development, and operational support.

Outreach

If we missed your news or data requires correction, the author can be reached at info@mismedical.com.

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