Jason M. Broderick

MRI before biopsy with prostate cancer screening was associated with both a clinical and cost-effectiveness benefit compared with a biopsy-first pathway.

The FDA is scheduled to decide on the new drug application by September 15, 2021.

PSA response rate was higher with the investigational radioligand therapy.

Following the recent FDA approval of tivozanib in renal cell carcinoma (RCC), the VEGF-TKI is now being explored in combination with the PD-1 inhibitor nivolumab in the phase 3 TiNivo-2 trial in patients with relapsed/refractory RCC.

A procedural code is now available to hospitals in France enabling use of UroLift to treat men aged ≥50 years with symptoms of an enlarged prostate up to 100 cc.

The application for the investigational testosterone replacement therapy is supported by findings from the pivotal phase 3 ReTUNE trial, as well as a 6-month extension study of that trial.

The FDA has approved tivozanib for kidney cancer.

“The most important finding is that post-abiraterone, [bipolar androgen therapy] can markedly improve the magnitude and duration of response to enzalutamide,” the authors wrote.

The retrospective study compared reintervention rates in the 4 standard surgical interventions for lower urinary tract symptoms due to benign prostatic obstruction.

The safety and efficacy of the locally administered fusion protein were assessed in the phase 3 VISTA trial.

The investigational padeliporfin ImPACT platform involves the intravenous delivery of the photosensitive drug padeliporfin, which is then activated by a non-thermal light delivery system.

The withdrawal comes after the confirmatory phase 3 IMvigor211 study missed its primary end point.

The FDA is currently reviewing the results of these trials and is scheduled to make an approval decision by May 28, 2021.

The RNAi drug nedosiran is a once-monthly subcutaneous injection under investigation for all 3 types of primary hyperoxaluria.

The European Commission is reviewing data from the pivotal phase 3 CheckMate-9ER trial.

The outcome of the Decipher Prostate test was independently associated with overall survival, prostate cancer–specific mortality, and risk of metastasis.

Tadfin is a once-daily capsule that combines 5 mg of tadalafil (Cialis) with 5 mg of finasteride (Proscar).

Adding the off-the-shelf, cell-based immunotherapy ilixadencel to frontline sunitinib was associated with an overall survival benefit in patients with metastatic renal cell carcinoma.

The rechargeable implantable neurostimulator is approved for the treatment of patients with urinary and bladder dysfunction.

Abiraterone/prednisone can increase survival in prostate cancer; however, most patients develop resistance between 9 and 16 months after starting treatment.

The withdrawal comes after the confirmatory phase 3 DANUBE trial missed its primary end points.

The updated label expands the range of MRI scan parameters and allows a briefer waiting period between MRI scans.

Two supplemental Biologics License Applications have been submitted to the FDA for the antibody-drug conjugate.

“These findings support the importance of genomic testing to identify patients eligible to consider olaparib treatment,” said Johann de Bono, MB CHB, PhD, MSC.

The safety and efficacy of the locally administered fusion protein were assessed in the phase 3 VISTA trial.

The FDA is scheduled to make a decision on a new drug application for 18F-DCFPyL on or before May 28, 2021.

There was a trend toward better overall survival outcomes with the apalutamide/abiraterone combination in certain prespecified biomarker subgroups.

The study assessed factors associated with survival outcomes in patients with metastatic clear cell renal cell carcinoma receiving immune checkpoint inhibitors.

The investigators also determined independent factors affecting the efficacy of vibegron in this setting.

FDA new drug application filing expected by the end of 2021.