Pfizer, Merck KGaA's Bavencio Gains Bladder Cancer Indication

An immuno-oncology drug developed by Pfizer and EMD Serono, a subsidiary of Germany’s Merck KGaA, officially gained its second treatment indication in less than two months.

The Food and Drug Administration (FDA) on Tuesday granted accelerated approval to Bavencio (avelumab) to treat patients with locally advanced or metastatic urothelial carcinoma, which is an aggressive form of bladder cancer that has a high rate of recurrence.

It can be prescribed for patients diagnosed with either form of the condition 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, according to the official announcement.

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

The FDA made their decision after reviewing tumor response and response duration results from a phase 1 open-label study exploring Bavencio’s safety and efficacy profiles with 242 patients diagnosed with this disease.

Investigators administered 10 mg/kg intravenously of Bavencio to patients every 2 weeks until signs of radiographic or clinical progression or unacceptable toxicity emerged.

Results indicated the overall response rate was an estimated 13.3 percent in patients taking Bavencio who had been followed for at least 13 weeks whereas it being 16 percent for patients who had been followed for at least 6 months.

“This approval builds on the ongoing clinical development program for BAVENCIO in urothelial carcinoma and reinforces our commitment to providing new medicines to patients with difficult-to-treat cancers,” said Global President of Pfizer Oncology Liz Barrett, in a statement. By drawing on the strength of the alliance, as well as Pfizer’s deep experience in genitourinary cancers, we believe BAVENCIO will be an important treatment option, and we hope it will help to improve outcomes for these patients.”

Bavencio belongs to a class of drugs called PD-L1 or PD-1 inhibitors, reported Reuters. These treatments work by blocking a technique tumors use to evade detection therefore helping the immune system combat cancer.

The drug gained approval in March for a rare form of skin cancer called Merkel Cell carcinoma, but this new indication makes it the fourth immunotherapy approved for advanced bladder cancer.

Next, both companies will will perform another clinical trial in order to confirm the drug could extend survival rates.