Hannah Clarke

The revised policy will take effect on January 1, 2025.

In total, the study plans to enroll 84 adult patients across clinical trial sites in the United States and Australia.

“Based on these data, casdatifan has the potential to be a future treatment option for kidney cancer," says Toni K. Choueiri, MD.

The UUI responder rate was 71.8% among those who received SNM and 71.3% among those who received iTNM.

A rapid reduction in E coli in the urine was observed among 10 of 16 evaluable patients at 4 hours following the first treatment.

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.