Brittany Lovely

Catch up on all the notable drug and device approvals in urology over the past year.

The positive CHMP opinion is supported by findings from cohort 1 of the phase 3 THOR trial.

The approval is based on results from the phase 3 THOR trial.

The EU application for erdafitinib in urothelial carcinoma is supported by data from cohort 1 of the phase 3 THOR trial.

Erdafitinib previously received an accelerated approved for the treatment of adult patients with FGFR2/3-positive, previously-treated locally advanced or metastatic urothelial carcinoma.

In this patient population, erdafitinib reduced the risk of death by 36% versus physician's choice of chemotherapy.

“This represents one of the largest reported in the phase 3 trials in first-line mCRPC,” says investigator Noel W. Clarke, MBBS, FRCS, ChM.

“Responses occurred across all International mRCC Database Consortium risk groups—both in the favorable and intermediate/poor risk groups,” said Jamie R. Merchan, MD.

“[Mitomycin gel] is efficacious as a [chemoablation] agent in adult patients with low-grade upper tract urothelial cancer, and while it’s FDA approved for both antegrade and retrograde administration, prior reports are limited to the retrograde experience,” said study investigator Kyle Rose, MD.

The 12-month recurrence-free survival rate was 42.9% for those who received BCG alone compared with 44.4% for those who received the combination.

Long-term findings from 2 cohorts of a phase 3 study showed sustained efficacy with the novel intravesical gene therapy in patients with BCG-unresponsive non–muscle invasive bladder cancer.

Antibody titers and fold changes may prove to be a prognostic marker for the efficacy of nadofaragene firadenovec.

The addition of avelumab to standard first-line gemcitabine/carboplatin did not improve outcomes in patients with metastatic urothelial carcinoma.