Hannah Clarke

The decision comes after a pre-specified futility analysis determined that it was unlikely that the study would meet its primary end point.

Anti-tumor activity was observed across all patients with FGFR3-altered metastatic urothelial carcinoma who were treated at the dose levels of 90 mg and higher.

The NDA submission is supported by data from a single-arm, phase 3 trial of leuprolide mesylate administered as 2 injections, 3 months apart.

The RMAT designation is supported by interim data from the ongoing phase 1 TRAVERSE trial.

“The majority (76%) of patients not yet meeting the Phoenix criteria did have PSMA-avid lesions on PSMA-PET, suggesting [prostate cancer] recurrence," says Evelien J E van Altena.

The phase 3 ENVISION trial met its primary end point by demonstrating a 79.6% complete response rate at 3 months following the first instillation of the therapy.

“These findings support the safety of vaginal estrogen for treatment of local menopause symptoms, even in high-risk women,” says Gabriella M. Rustia, MD.

The approval is supported by data from the phase 3 SURE 1 and REASSURE trials.

The therapeutic response rate was 79% at 24 months, which is comparable to the rates seen at 6 months (78%) and 12 months (82%).

At 1 month, the mean decrease in the OAB-Q symptom severity subscale score was -31.2 in the 1-injection cohort vs -39.5 in the 10-injection cohort.

Patients with higher baseline HEI and E-HEI scores were less likely to experience grade reclassification.

The cystoscopy solution was granted a CE mark for regulatory clearance in Europe in October 2023.

The trial is comparing the diagnostic performance of 61Cu-NODAGA-PSMA I&T with that of 18F-piflufolastat.

The codes will go into effect on January 1, 2026.

None of the videos mentioned the long-term impact of exogenous testosterone on spermatogenesis.

The decision to withdraw sacituzumab govitecan from the market was made in consultation with the US FDA following negative data from the phase 3 TROPiCS-04 trial.

Almost all studies (93.5%) reported an improvement in validated patient-reported outcomes following treatment.

Overall, 4 of 5 patients with low-grade disease who received bel-sar with light activation achieved a complete clinical response.

At 5 years, 95.8% of patients in the SBRT arm were free from biochemical or clinical failure compared with 94.6% of patients in the control radiotherapy arm.

Data from the EMPIRE-2 trial also showed that 18F-fluciclovine resulted in significantly more boosts to the prostate bed.

The target action date for the application is June 13, 2025.

Overall, 15/16 patients had a true positive scan based on confirmatory imaging and/or biopsy, equating to a PPV of 93.75%.

The application is supported by data from the pivotal phase 3 ARANOTE trial.

Patient recruitment for the phase 3 AMPLIFY trial is set to begin early next year.

Both 177Lu-PSMA-I&T and 64Cu-PSMA-I&T are currently in phase 3 development for use in prostate cancer diagnostics and treatment.

“Nivolumab, combined with standard of care trimodality therapy, appears to be promising for the treatment of grade group 5 prostate cancer," says John Michael Bryant, MD.

“While there are other treatment options available for treating BPH, there remains a significant need for much less invasive treatment approaches that can preserve and protect the integrity of the urethra and other critical structures," says Ryan Rhodes.

"Overall, TAR-200 is being tested with the aim of changing the therapeutic paradigm of patients with an early bladder cancer diagnosis, including non–muscle-invasive disease and muscle-invasive disease," says Andrea Necchi, MD.

"We remain on track for the opening of phase 2 in the next few months. We also expect to see the full phase 1 results presented at a scientific meeting in 2025," says David E. Gauden, DPhil.

Patients with elevated CTC count at baseline experienced poor complete response rates and worsened PFS and OS.