Next-Generation Imaging

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.

“What we've shown with our data and through our experience, is that by using this technology, we're able to preserve more normal kidney and disrupt less of the normal kidney,” says Michael D. Stifelman, MD.

“The negative predictive value we want to be high, and the false positive rate we want to be low. None of those beat the radiologist reads in both of those categories,” says Robert S. Wang, MD.

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.

"The challenge of treating men with high-risk disease and potential micro metastatic disease with this type of targeted therapy is really exciting," says David I. Lee, MD, FACS.

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.

"I think that this field is going to continue to evolve, especially when we think about how to incorporate PSMA-PET findings into our clinical care," says Todd M. Morgan, 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.

"A key piece of the guideline is that we need to offer radiation at a PSA of 0.5 ng/mL or lower and maybe even, for some patients, a PSA lower than 0.2 ng/mL," says Todd M. Morgan, MD.

"In terms of the minimal overlapping toxicity, our non-clinical data from the xenograft model showed minimal toxicity with the combination," says Caroline Foxton, 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.

"At Northwestern Medicine, we have very extensive and very deep experience with PET-PSMA-based imaging," says Edward M. Schaeffer, MD, PhD.

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.

"Like any test, it's really a very powerful tool. It's just how you deploy the tool," says Edward M. Schaeffer, MD, PhD.

"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.

In this video, Jaideep S. Sohi, MD, explains how the expanded information provided by PSMA-PET imaging allows physicians to more accurately tailor treatment plans for patients.

In this video, Jaideep S. Sohi, MD, explains factors to consider regarding the timing of re-imaging with PSMA-PET in patients with prostate cancer.