FDA Approves Medication for Advanced Bladder Cancer
The U.S. Food & Drug Administration (FDA) announced the accelerated approval of the medication enfortumab vedotin (EV) to treat adult patients with advanced urothelial or bladder cancer.
This FDA approval on December 18, 2019, is the direct result of a multi-institutional clinical trial led by Yale Cancer Center (YCC) and Smilow Cancer Hospital researchers, which demonstrated EV is an effective treatment for this deadly disease.
“This is very exciting progress as we haven’t had another therapy option for patients whose urothelial or bladder cancer has progressed after chemotherapy or immunotherapy,” said Daniel P. Petrylak, M.D., professor of medicine and urology.
“To my knowledge, this is the most active single drug in urothelial cancer. EV is described as a 'smart bomb.'”
Persuasive data from the trial were presented last June at the American Society of Clinical Oncology (ASCO) annual meeting.
Dr. Petrylak was the senior investigator of a clinical trial that studied the efficacy of EV for patients.
The single-arm, phase II EV-201 trial showed treatment with enfortumab vedotin—an agent targeting Nectin-4, a protein found in 97 percent of urothelial cancers—produced responses in 44 percent of patients with locally advanced or metastatic forms of urothelial cancer.
Patients had previously been treated with platinum chemotherapy and a programmed cell death protein 1 (PD-1) or programmed cell death ligand 1 (PD-L1) immune checkpoint inhibitor and had disease progression after their previous treatment.
“It’s gratifying to know Yale spearheaded the research effort to get this life-saving therapy to patients,” Dr. Petrylak concluded.
According to the American Cancer Society, urothelial cancer, also known as transitional cell carcinoma (TCC), is the most common type of bladder cancer (90 percent of cases).
Approximately 81,000 people in the U.S. are anticipated to be diagnosed with bladder cancer during 2018. Bladder cancer is the 4th most common cancer in men but is less common in women.
Outcomes are poor for people diagnosed with metastatic disease, with a 5-year survival rate of just 4.8 percent.
There is no routine screening recommended, so most people do not undergo any tests to detect bladder cancer unless they experience symptoms.
Signs and symptoms of the disease include blood in the urine, painful or frequent urination, urinary incontinence, and pain in the abdominal area.
The FDA granted the approval of EV to Astellas Pharma US Inc.
Bladder Cancer news published by Vax-Before-Cancer
- Results of enfortumab vedotin monotherapy for locally advanced or metastatic urothelial cancer previously treated with platinum
- FDA grants accelerated approval to enfortumab vedotin-ejfv for metastatic urothelial cancer
- Yale Cancer Center
- Seattle Genetics and Astellas Announce Progress in Enfortumab Vedotin Urothelial Cancer Clinical Development Program