Bladder Cancer

The FDA has granted approval to enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer.

During a Targeted Oncology Case-Based Roundtable event, Daniel A. Landau, MD, moderated a discussion around the JAVELIN trial and how its results were practice changing for oncologists treating for bladder cancer.

Fosciclopirox will be investigated for the treatment of newly-diagnosed and recurrent bladder cancer in a phase 2 study.

An FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.

In an interview with Targeted Oncology, Parminder Singh, MD, discussed the need for bladder-sparing therapies in an older patient population of muscle-invasive bladder cancer and the findings from the INTACT clinical trial.

In patients with muscle-invasive bladder cancer treated in the phase 2 HCRN GU16-257 trial, the combination of transurethral resection of the bladder tumor with nivolumab and chemotherapy showed promise.

In patients with muscle-invasive bladder cancer combining transurethral resection of the bladder tumor with nivolumab and chemotherapy showed promise as a bladder-sparing treatment strategy.

The protocol of pembrolizumab in combination with gemcitabine and concurrent hypofractionated radiotherapy for muscle-invasive bladder cancer demonstrated safety and efficacy.

Across several previously unreported subgroups of patients with advanced urothelial cancer who have progressed on first-line platinum-containing chemotherapy avelumab as frontline maintenance plus best supportive care demonstrated a survival benefit compared with BSC alone.

In an interview with Targeted Oncology, Risa Wong, MD, discussed platinum versus non-platinum containing chemotherapy as a later-line treatment for metastatic urothelial carcinoma.

Immunotherapies are now accepted treatments in the maintenance and second-line settings for patients with metastatic urothelial cancer and in the setting of superficial UC–carcinoma in situ with prior intravesical therapy, according to updated NCCN guidelines

Yousef Zakharia, MD, discusses the results of a phase 2 trial investigating concurrent durvalumab and radiation therapy followed by adjuvant durvalumab in patients with localized urothelial cancer of bladder.

Helen Moon, MD, reviewed the data from the JAVELIN Bladder 100 trial, which support the use of avelumab as maintenance therapy for patients with metastatic bladder cancer.

The FDA has accepted a Biologics License Application for nivolumab for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and granted it Priority Review.

The FDA’s Oncologic Drug Advisory Committee voted 10 to 1 to continue the accelerated approval of atezolizumab for the frontline treatment of patients with urothelial cancer who are ineligible for cisplatin.

The FDA’s Oncologic Drugs Advisory Committee voted 5 to 3 in favor of continued approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy.

During a virtual Targeted Oncology Case-Based Roundtable event, Daniel P. Petrylak, MD, discussed the case of a 66-year-old woman with metastatic bladder cancer.

Avelumab is considered a new standard-of-care treatment for patients with advanced urothelial carcinoma who have not progressed on frontline platinum-containing chemotherapy after the agent demonstrated overall survival improvement for this patient population in a phase 3 clinical trial setting.

Findings from a A phase 3 trial evaluating adjuvant nivolumab following surgery versus placebo demonstrated an improvement in median disease-free survival in patients with muscle-invasive urothelial cancer, according to results from the CheckMate 274 trial presented at the 2021 Genitourinary Cancers Symposium.

The FDA has granted priority review for 2 supplemental biologics license applications for enfortumab vedotin-ejfv for the treatment of a subset of patients with locally advanced or metastatic urothelial cancer.

It is not uncommon to have studies of nearly identical agents in nearly identical settings yield conflicting results, says Arjun V. Balar, MD.

An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor.

Thomas Hutson, DO, PharmD, discussed the case of a 66-year-old patient with bladder cancer during a virtual Targeted Oncology Case-Based Roundtable event.

During a virtual Targeted Oncology Case-Based Roundtable event, Anish B. Parikh, MD, discussed front-line treatment options for metastatic urothelial cancer as well as the data supporting avelumab maintenance.

Atezolizumab (is being voluntarily withdrawn from the US market by Roche for its indication as a treatment for patients with prior-platinum treated metastatic urothelial carcinoma.

The FDA has granted an Orphan Drug Designation to Padeliporfin Immune Photo Activated Cancer Therapy for the treatment of adult patients with upper tract urothelial cancer.

A promising efficacy signal was observed when the immune checkpoint inhibitor durvalumab was added concurrently to radiation followed by adjuvant durvalumab as treatment of patients with localized urothelial bladder cancer.

In an interview with Targeted Oncology, Shaakir Hasan, DO, discussed the results found when diagnostic and treatment information from patients with bladder cancer was prospectively assessed. He also discussed future work on disparities in health care in an interview with Targeted Oncology.

The durvalumab indication as a treatment for previously treated adult patients with locally advanced or metastatic bladder cancer has been voluntarily withdrawn in the United States by AstraZeneca, the developer of the PD-L1 inhibitor, the company announced in a press release.

The submission of 2 Biologic License Applications for enfortumab vedotin-ejfv have been made to the FDA for consideration as treatment of patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and who are ineligible for cisplatin.