Immuno-oncology bladder drug wins approval

Soon after approving the same drug for metastatic Merkel cell carcinoma, FDA approved immuno-oncology avelumab (Bavencio, EMD Serono/ Merck and Pfizer) for locally advanced or metastatic urothelial carcinoma (UC).

FDA first approved Bavencio in late March to treat adults and pediatric patients aged 12 years and older with MCC, including those who have not received prior chemotherapy. Then, in mid-May, FDA said that Bavencio could be marketed to those with UC, who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

Read: First drug for rare skin cancer wins approval

The UC drug will be available in the U.S. for around $13,000 per month.

"This approval for Bavencio in patients with locally advanced or metastatic urothelial carcinoma exemplifies our unwavering commitment to finding new treatments for the most challenging cancers," said Luciano Rossetti, MD, executive vice president, global head of research & development, at the biopharma business of Merck KGaA,” in a statement from Merck and Pfizer.

Bladder cancer makes up approximately 90% of urothelial carcinomas and is the sixth most common cancer in the United States. When the disease has metastasized, the 5-year survival rate is approximately 5%.

"Once urothelial carcinoma progresses after treatment with chemotherapy, the five-year survival rate is alarmingly low," said Andrea Apolo, MD, with the National Cancer Institute in Bethesda, Md., in the statement. "Until recently, there had been limited innovation in urothelial carcinoma, and this approval gives us another treatment to help battle this aggressive disease."

Read: Advanced ovarian cancer drug approved

The efficacy and safety of Bavencio was demonstrated in a phase 1, open-label, single-arm, multicenter study of Bavencio in the treatment of various solid tumors. The study included 242 patients with locally advanced or metastatic urothelial carcinoma with disease progression on or after platinum- containing chemotherapy or who had disease progression within 12 months of treatment with a platinum-containing neoadjuvant or adjuvant chemotherapy regimen.

The data will be presented at an upcoming medical congress.

The international clinical development program for avelumab, known as JAVELIN, involves more than 30 clinical programs, including 9 phase 3 trials, and more than 5,200 patients across more than 15 tumor types.   

Despite the drug’s high-price tag, Pfizer and Merck said they are committed to providing patient access and reimbursement support through their CoverOne program. CoverOne can be reached at 844-8COVER1 (844-826-8371) or at www.CoverOne.com.

Read next: Breakthrough lymphoma drug on the horizon