Jason M. Broderick

Flotufolastat F 18 was granted FDA approval on May 25, 2023 based on data from the phase 3 SPOTLIGHT and LIGHTHOUSE trials.

The approval is based on findings from the phase 3 TALAPRO-2 trial.

The theranostic 64Cu/67Cu-SAR-BBN combines the imaging product 64Cu-SAR-BBN and the targeted therapy 67Cu-SAR-BBN.

The investigators assessed data from the UNITE study, a retrospective study of patients treated with enfortumab vedotin and other agents.

Clinical research has demonstrated a 10-minute onset interval for the topical gel formulation MED3000, compared to an interval of at least 30 minutes with PDE5 inhibitors, such as Cialis and Viagra.

"The addition of an immune checkpoint inhibitor after tri- or tetra-modality therapy might improve long-term outcomes for patients with bladder cancer,” said Maria De Santis, MD.

Disitamab vedotin is a HER2-targeted antibody-drug conjugate and toripalimab is a PD1-inhibitor.

At a median follow-up of about 50 months, lenvatinib plus pembrolizumab maintained an overall survival benefit compared with sunitinib in patients with advanced renal cell carcinoma.

Belzutifan plus lenvatinib elicited promising antitumor activity with a manageable safety profile as a second-line or later treatment for patients with advanced renal cell carcinoma.

The phase 3 PROpel trial provided the primary supporting data for the approval.

The approval of flotufolastat F 18 (formerly 18F-rhPSMA-7.3) in prostate cancer is based on findings from the phase 3 SPOTLIGHT and LIGHTHOUSE trials.

The theranostic 64Cu/67Cu SAR-bisPSMA yielded positive safety and efficacy signals in patients with metastatic castration-resistant prostate cancer.

Adding cabozantinib to nivolumab/ipilimumab improved PFS in frontline renal cell carcinoma; however, there was increased toxicity with the triplet, including more adverse event–related discontinuations.

The FDA has issued a complete response letter to ImmunityBio regarding its biologics license application for N-803 (Anktiva) for use in combination with BCG for the treatment of patients with non–muscle-invasive bladder cancer.

In the ARASTEP trial, the primary outcome measure of rPFS is being measured by PSMA-PET/CT imaging with 68Ga-PSMA-11 (prepared using Illuccix) or piflufolastat F 18.

Illuccix is approved by Health Canada for imaging in patients with suspected metastasis who are candidates for initial definitive therapy, or in patients with suspected recurrence based on an elevated PSA level.

Treatment with the Optilume BPH System resulted in significant, immediate symptomatic and functional improvements in patients with BPH, according to 12-month data from the PINNACLE study.

The indication is restricted from the indication in the FDA supplemental New Drug Application for olaparib/abiraterone, which is for the population at-large in the BRCA–mutation positive setting.

“Zenflow is a novel minimally invasive surgical therapy that delivers a nitinol device into the prostatic urethra displacing the lateral lobes for improved urinary flow,” explained Dean Elterman, MD.

Beyond demonstrating clinical activity, pembrolizumab was safe and tolerable in this patient population.

The novel intravesical chemotherapy delivery system TAR-200 elicited complete responses in nearly three-fourths of patients with BCG-unresponsive, high-risk non–muscle-invasive bladder cancer.

The patients’ preference for vibegron could be depending on the better efficacy for urgency incontinence, said Naoki Wada, PhD.

The results provide further evidence of the “obesity paradox” in patients with renal cell carcinoma.

The overall survival benefit of darolutamide in the North American population as a whole was also specifically observed in Black/African American patients.

“The benefits of FAP-PET imaging include the higher specificity compared to conventional imaging. There's also the potential for upstaging,” said Domenique Escobar, MD.

A database analysis of patients who participated in the STAMPEDE trial showed that zoledronic acid can significantly lower the risk of fracture in patients with with metastatic hormone-sensitive prostate cancer starting long-term ADT.

The designation is for patients with mCRPC who have progressed on an androgen receptor pathway inhibitor and are not eligible for or decline to receive chemotherapy.

The PSMA-targeted fluorescent tracer OTL78 was shown to be safe and enabled real-time imaging during robot-assisted radical prostatectomy and provided valuable information on the localization and extent of prostate cancer.

Clinical guidelines currently do not recommend PSMA-PET imaging before radical prostatectomy.

“We recommend mirabegron monotherapy as an alternative medical treatment choice for the management of OAB,” the authors wrote.