Two signals arrived from opposite ends of the PSMA pipeline this week: the FDA granted Fast Track designation to Vir Biotechnology and Astellas’s non-radioactive, PSMA-targeted T-cell engager VIR-5500 for late-line mCRPC, while a Journal of Nuclear Medicine study showed PSMA-PET-guided biopsy nearly doubling cancer detection in men whose MRI missed it. Treatment and diagnosis are both getting sharper at once, and neither development depends on adding another lutetium slot to the schedule.

Cleveland Clinic published a clinical perspective on Pluvicto’s FDA approval for mHSPC, featuring Dr. Shilpa Gupta, a PSMAddition principal investigator and genitourinary oncologist at Cleveland Clinic Cancer Institute, the trial’s highest-enrolling U.S. site. The FDA approved 177Lu-PSMA-617 (Pluvicto) plus an ARPI for PSMA-positive metastatic hormone-sensitive prostate cancer on July 31, 2026, based on the phase 3 PSMAddition trial published in The Lancet; the interim analysis showed a 28% reduction in risk of radiographic progression or death (HR 0.72, P=.002) against ADT plus ARPI alone. It is the first radioligand therapy approved in this earlier-stage setting, and the October 9 piece is the first institutional read we’ve seen on what that means for referral pathways.

A Journal of Nuclear Medicine study found PSMA-PET/CT-targeted biopsy detected clinically significant prostate cancer in 37% of men with negative or inconclusive MRI, versus 21% with systematic biopsy alone; SNMMI estimates 20–30% of significant cancers are missed under MRI-first protocols.

The FDA granted Fast Track designation to Vir Biotechnology and Astellas’s VIR-5500 for late-line mCRPC; phase 1 data showed an 82% PSA50 response rate and a 45% objective response rate at the highest dose, with grade 3+ events in 12% of patients.

Clarity Pharmaceuticals completed enrollment of its SECuRE trial’s Cohort Expansion main group, each of 16 participants receiving up to six cycles of 8 GBq 67Cu-SAR-bisPSMA; earlier data at that dose showed 81% disease control and 5 complete responses.

GE HealthCare agreed to buy PET radiopharmaceutical manufacturer SOFIE Biosciences for $945 million in cash, gaining 15 U.S. cyclotron sites and U.S. rights to FAPI-74, a phase 3 pan-cancer PET radiotracer; the deal is expected to close in the first half of 2027.

Telix reported its first U.S. commercial doses of Pixclara (floretyrosine F 18), its FDA-approved brain cancer imaging agent, about three weeks after FDA approval — the company’s first U.S. product outside prostate cancer imaging.

Jubilant Radiopharma will invest CAD 94.5 million to modernize its Kirkland, Quebec biomanufacturing site, backed by a CAD 23.8 million Government of Canada grant, creating or maintaining 225 jobs.