Diana’s Opening Note

I have spent most of the past month writing about demand: a wider Pluvicto label, more men eligible, more scans to schedule. This week the industry showed me the other side of the ledger. The FDA declined to approve a radioligand therapy for reasons that had nothing to do with whether it works. If you run a theranostics program, that is the sentence to sit with this weekend.

Editor’s Spotlight

The Complete Response Letter for ITM’s 177Lu-edotreotide named chemistry, manufacturing and controls items and a third-party commercial facility. It named no clinical or safety concern and requested no additional data. In the same week, Curium closed its second transaction in eight days and Lantheus reported a quarter it declined to discuss on a call because it is on its way to being taken private. Capacity, supply, and ownership are all moving faster than the evidence base, and they are what will decide whether a program can put a dose in a patient’s arm on the day it is scheduled.

Story of the Week

ITM disclosed on August 10 that it received a Complete Response Letter dated August 7 for its new drug application covering 177Lu-edotreotide (ITM-11) in gastroenteropancreatic neuroendocrine tumors. The agency said it cannot approve the application in its present form and cited chemistry, manufacturing and controls items together with third-party commercial facility inspection matters. It identified no concerns with the clinical or nonclinical data package or with the safety profile, and requested no new studies. The pivotal COMPETE trial, which met its primary progression-free survival endpoint against everolimus, is unaffected, and ITM says it intends to resubmit once the cited items are addressed. For programs that had penciled in a second lutetium-based therapeutic option this year, the practical answer is that the science held and the plant did not.

Clinical News

A Stanford series of 158 men with metastatic castration-resistant prostate cancer found that early same-day post-therapy whole-body SPECT/CT, read with visual RECIP 1.0 after cycle 2 of 177Lu-PSMA-617, was associated with overall survival: 21.5 months with an imaging response versus 11.3 months without. Combining imaging response with baseline tumor volume and a PSA decline of at least 50% before cycle 3 stratified further, to 23.7 versus 10.6 months. SPECT, PSMA PET and PSA responses agreed in about 60% of patients, so the scan complements rather than replaces the others.

A 99-patient French cohort tested whether FDG PET adds prognostic value beyond PSMA PET before Lu-PSMA therapy. Baseline PSMA PET SUVmean was the only significant imaging predictor of survival; adding FDG total metabolic tumor volume improved the concordance index by just 0.010, though it did refine risk in the subset with high FDG burden. Median overall survival in the cohort was 14 months. The practical read is that routine dual-tracer imaging is hard to justify for every patient, but remains defensible in selected high-risk cases.

The Journal of Nuclear Medicine also published the LPS-Boost trial protocol, which tests intensified 177Lu-PSMA-617 dosing in men whose PSMA PET shows low tracer expression. That group has consistently responded least well to standard dosing, and it is the population most likely to be widened by earlier treatment in hormone-sensitive disease.

Business & Industry Intelligence

The ITM Complete Response Letter is the clearest signal yet that manufacturing readiness, not evidence generation, is now the rate-limiting step in radiopharmaceutical approvals. The cited items sit at a third-party commercial facility, which means the fix depends on a partner’s timeline as much as ITM’s own.

Curium completed its acquisition of Belgian clinical-stage Abscint SA on August 10, taking global rights to develop, manufacture and commercialize ABS-011, an investigational gallium-68 single-domain antibody PET tracer targeting HER2. The asset is in the Phase 2b HERMIA trial in Belgium. Coming eight days after the $8.0 billion Lantheus merger agreement, it shows Curium building a diagnostic pipeline beyond prostate at the same time it consolidates supply.

Lantheus reported second-quarter revenue of $388.2 million, up 2.7% year over year, with Pylarify at $240.4 million, down 4.1%, and Definity up 5.2% to $88.3 million. Because the Curium transaction is pending, the company suspended its 2026 guidance and did not hold an earnings call. The deal is expected to close in the first half of 2027, after which Lantheus will no longer be publicly traded.

Practice Insights

Make post-therapy SPECT/CT after cycle 2 a standing part of your Lu-PSMA protocol. The Stanford data turn the same-day post-therapy scan into an early survival signal rather than a dosimetry by-product, and it costs almost nothing to add because the patient is already in the department. Agree a visual RECIP 1.0 read with nuclear medicine, pair it with a PSA50 check before cycle 3, and use the combination to decide who continues, who switches, and where scarce therapy slots go. Separately, ask each vendor which facility manufactures each dose you administer and when that site was last inspected. This week showed what happens when the answer is somebody else’s problem.

Clinical Trials to Watch

SECuRE (Clarity Pharmaceuticals) — nineteen patients treated at the 8 GBq 67Cu-SAR-bisPSMA dose level as of the July 20 cut-off: 63% reached PSA50, 81% of those evaluable achieved disease control, and five achieved complete response or undetectable disease.

COMPETE (ITM) — the primary progression-free survival endpoint stands, but the application now needs manufacturing and third-party facility items resolved before resubmission.

HERMIA (Curium, formerly Abscint) — Phase 2b of the gallium-68 HER2 tracer ABS-011 in Belgium, now backed by Curium’s development and manufacturing scale.

LPS-Boost — intensified 177Lu-PSMA-617 dosing for low PSMA-expressing metastatic castration-resistant prostate cancer; the protocol was published this week.

Industry Movers / News in Brief

Radnostix closed out its FDA Form 483 corrective actions and completed the Lucerno Dynamics asset purchase, restoring capsule inventory by the end of June and moving the former International Isotopes into medical devices alongside isotope supply. Second-quarter revenue fell 27% to $2.67 million on the residual effects of two voluntary recalls and a cobalt hot-cell shutdown, with order volumes normalizing in July.

Clarity’s 67Cu-SAR-bisPSMA program has now produced seven complete responses or undetectable disease across all cohorts, five of them at the 8 GBq dose level, in patients who had received a median of five prior anti-cancer regimens.

ASTRO 2026 runs September 26-30 in Boston; EANM’26 follows October 17-21 in Vienna; ESMO 2026 is October 23-27 in Madrid; and the SNMMI Theranostics Conference runs November 4-7 in Bethesda.

Diana’s Take

The ITM letter is the week’s real lesson. The clinical evidence was not the problem; a third-party facility was. As radioligand therapy moves earlier in the disease course and volumes rise, supply chains and inspection readiness decide who can actually deliver a dose on the day a patient is scheduled. Ask each vendor where the dose is made, who last inspected that site, and what the backup route is. Ask before you need the answer.

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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