Next-Generation Imaging

The median PFS with PSMA PET/CT-guided MDT was 33.2 months, vs 13.8 months with choline PET/CT-guided MDT.

Telix must resubmit the BLA with remediations in order to advance the application to full review, which the company expects to be able to complete within approximately 90 days.

“I think the use and the appropriateness of these agents along the patient journey is also coming into question,” says Brian T. Helfand, MD, PhD.

Data showed a patient-level detection rate of 93% with flotufolastat F 18 in African American patients.

The PDUFA goal date for TLX007-CDx is March 24, 2025.

The first commercial doses of the diagnostic have now been administered in both Austria and France.

“The ability to gather actionable information from PSMA PET scans is important for physicians to make informed decisions about patient management for men with prostate cancer,” says Eugene Teoh, MBBS, MRCP, FRCR, DPhil.

The BLA submission is supported by findings from the phase 3 ZIRCON trial, which demonstrated high specificity and sensitivity of TLX250-CDx for PET/CT imaging of ccRCC.

Patients with high-risk disease were shown to have a significantly higher mean value of SUVmax compared with patients with low-risk disease (23.5 ± 13.2 vs 10.6 ± 5.4; P < 0.05).

"This announcement is an important step in increasing the awareness and accessibility of OnQ Prostate beyond its earliest adopters, so that more physicians and patients can benefit from this technology," says Brittany Hunt.

“If approved by the FDA, this new product will have a significant impact on prostate cancer patients, physicians, and their caregivers by helping to eliminate the inequity of access to PSMA-PET agents, and increase the ability to accurately diagnose cancer early, reducing the cost of care, and increasing the probability of patients’ survival," says Mike Crosby.

The phase 2/3 AlphaBreak trial is evaluating the safety and efficacy of FPI-2265 in patients with mCRPC who have been previously treated with 177Lu-PSMA radiotherapy.

"This was a very special moment, delivering the news to this patient that his cancer is now undetectable following the treatment with 2 doses of 8 GBq of 67Cu-SAR-bisPSMA," says Luke Nordquist, MD, FACP.

A late phase 3 trial evaluating the agent is underway at several clinics in Europe.

The first patient was treated with TLX250-CDx at the Olivia Newton-John Cancer Wellness Centre at Austin Health in Melbourne, Australia,

Both the SOLAR-STAGE and SOLAR-RECUR trials are currently enrolling patients with prostate cancer in the US, with additional sites expected to open in Europe later this year.

"The advance of PSMA imaging has put an emphasis on multidisciplinary care," says Kenneth J. Pienta, MD.

“In the future, this imaging technique can help to streamline the drug development process, driving conviction in the agents we bring to larger scale trials," says Stephen Rose, PhD.

Since piflufolastat (18F) was granted marketing authorization by the European Commission in July 2023, doses have been commercially sold in Greece, Italy, and the Netherlands.

The expanded label for 177Lu-PSMA-617 would include patients with mCRPC in the pre-taxane-based chemotherapy setting.

Convergent plans to conduct phase 2 clinical trials of 225Ac-J591 in prostate cancer in 2024, with a registrational program set to begin in 2025.

"PSMA PET imaging is used in the initial diagnostic staging and then in subsequent cases where there can be a recurrence after primary treatment.," says Edward M. Schaeffer, MD, PhD.

With the dosing of the first patient in Italy, Telix’s expanded access program for TLX250-CDx in ccRCC now includes 3 active countries, including the Netherlands and the US.

"PSMA-PET is a radio nucleotide-based imaging modality that really has changed the landscape of how we initially stage and subsequently follow individuals who have a diagnosis of prostate cancer," says Edward M. Schaeffer, MD, PhD.

Among all patients treated in the study to date, 60% demonstrated a PSA reduction of greater than 35%, and 27% demonstrated a PSA reduction of greater than 80%.

"There are patients who are not able to be submitted to an MRI due to metallic artifacts or to some conditions that are not compatible with the performance of an MRI," says Leonardo Kayat Bittencourt, MD, PhD.

The therapy is currently being manufactured in Italy at Curium facilities in Milan.

In this interview, Robert Reiter, MD, MBA, discusses the accuracy of PSMA-PET scans, false negative and false positive rates, and how treatment with ADT affects PSMA uptake.

"There are situations where you can use a biparametric or noncontrast approach; most of them you will prefer still to use an approach with contrast," says Leonardo Kayat Bittencourt, MD, PhD.

"We have information today from a number of well-powered, well-designed prospective studies showing that performing an MRI before the decision to do the first biopsy adds value," says Leonardo Kayat Bittencourt, MD, PhD.