FDA Grants Accelerated Approval to Sacituzumab Govitecan for Metastatic Urothelial CancerApril 13th 2021
Based on results of the phase 2 TROPHY-U-01 trial, the FDA has given accelerated approval to sacituzumab govitecan for previously treated, locally advanced or metastatic urothelial carcinoma.
Updated Standard Practice for Managing Patients with Non-Muscle-Invasive Bladder CancerMarch 13th 2021
Leonard G. Gomella, MD, FACS, detailed updated information regarding the standard of care and overall management of patients with non-muscle invasive bladder cancer at the 2021 New York GU 14th Annual Interdisciplinary Prostate Cancer Congress®.
Management of Upper Tract Urothelial Tumors With Conservative Management, Mitomycin GelMarch 12th 2021
Scott G. Hubosky, MD, of Jefferson University Hospitals, discussed methods of treating patients with upper tract urothelial carcinoma at the 2021 New York GU 14th Annual Interdisciplinary Prostate Cancer Congress®.
Atezolizumab Indication in US Withdrawn for Previously Treated Metastatic Urothelial CancerMarch 8th 2021
As part of an industry-wide assessment of indications based on accelerated approval, Roche in consultation with the FDA has decided to withdraw the indication for atezolizumab in patients with urothelial carcinoma following platinum-based chemotherapy.
Lower-Dose Hypofractionated Radiotherapy Schedule Proves Effective for Patients With Locally Advanced Bladder CancerFebruary 25th 2021
Data published in The Lancet Oncology found that a hypofractionated radiation schedule of 55 Gy in 20 fractions is noninferior to a schedule of 64 Gy in 32 fractions for patients with this disease.
AstraZeneca Withdraws Durvalumab Indication for Previously Treated Locally Advanced or Metastatic Bladder CancerFebruary 22nd 2021
Continued approval for durvalumab in previously treated adult patients with locally advanced or metastatic bladder cancer was dependent upon results from the phase 3 DANUBE trial in the first-line metastatic bladder cancer setting, which did not meet its primary end points in 2020.
FDA Grants Priority Review to BLA for Vicineum for Treatment of High-Risk, BCG-Unresponsive NMIBCFebruary 18th 2021
The biologics license application is for the locally administered fusion protein Vicineum for the treatment of high-risk, bacillus Calmette-Guérin (BCG)–unresponsive non-muscle invasive bladder cancer.
Efficacy With Enfortumab Vedotin for Cisplatin-Ineligible Urothelial Cancer Shows Unmatched Response RatesFebruary 14th 2021
In patients with cisplatin-ineligible, locally advanced or metastatic urothelial cancer who received prior PD-1/PD-L1 inhibitors, enfortumab vedotin induced the highest response rates seen with any regimen in this setting.
Phase 3 Data Support Enfortumab Vedotin Benefit in Previously Treated Urothelial CarcinomaFebruary 13th 2021
Recently reported data continue to support the use of enfortumab vedotin in patients with advanced urothelial carcinoma who had previously been treated with chemotherapy and immunotherapy.
Patients with Cisplatin-ineligible mUC and High PD-L1 Expression Experience Clinical Benefit With AtezolizumabFebruary 12th 2021
Using the single-agent atezolizumab (Tecentriq) plus chemotherapy versus chemotherapy alone to treat patients in the front-line setting with cisplatin-ineligible IC2/3 advanced or metastatic urothelial carcinoma (mUC) revealed additional clinical evidence.
Frontline Therapy of Avelumab Showed Favorable OS Benefit in Japanese Patients With Advanced Urothelial CancerFebruary 11th 2021
Avelumab plus best supportive care as frontline maintenance therapy produced a favorable benefit-risk balance for Japanese patients with advanced urothelial cancer who did not progress on first-line chemotherapy.
FDA Approves Pembrolizumab for BCG-Unresponsive NMIBCFebruary 13th 2020
The FDA approved pembrolizumab (Keytruda) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or chose to not undergo cystectomy.
Counterpoint: Should Active Surveillance Be Used for Gleason 3+4 Prostate Cancer?June 19th 2019
In this Point/Counterpoint, Drs. Madueke and Abern argue that active surveillance should not currently be considered for patients with intermediate-risk prostate cancer.
Largest Race-Based Survival Advantage to Date Seen in Men Receiving Sipuleucel-T for Prostate CancerJune 12th 2019
A subanalysis of the PROCEED trial showed a surprisingly high survival advantage for a particular race of men receiving immunotherapy for metastatic castration-resistant prostate cancer.