Health Canada Approves BAVENCIO® For the Maintenance Treatment of Patients With Advanced Bladder Cancer

BAVENCIO is the first and only maintenance therapy for unresectable locally advanced or metastatic urothelial carcinoma (UC) approved by Health Canada

11 Jan 2021 | MISSISSAUGA, ON, Canada

EMD Serono Canada, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC announced that Health Canada has approved BAVENCIO® (avelumab) for the maintenance treatment of patients with unresectable locally advanced or metastatic UC whose disease has not progressed following first-line platinum-based chemotherapy.

“UC arises from the urinary tract and is the fifth most common cancer in Canada, accounting for 11,800 new cases and 2,500 deaths in 2019. In patients with locally advanced or metastatic UC, treatment options are limited and outcomes are poor,” says Dr. Srikala Sridhar, MD MSc FRCPC, Head of the Genitourinary Medical Oncologists of Canada, Associate Professor and Medical Oncologist at the Princess Margaret Cancer Centre. “Health Canada’s approval of BAVENCIO in this setting is great news for our patients and one of the most important treatment advancements in the field in over 15 years.”

“This is wonderful news for bladder cancer patients across Canada who now have another treatment option,” says Ferg Devins, Board Member of Bladder Cancer Canada. “This approval for a maintenance therapy will help provide more options to Canadian patients and provide hope to their loved ones.”

Reviewed under Health Canada’s Priority Review of Drug Submissions policy, BAVENCIO has been granted a notice of compliance (NOC) based on data from the Phase III JAVELIN Bladder 100 study. The Phase III JAVELIN 100 study, an open-label, parallel-arm, multi-centre study conducted in 700 patients treated with BAVENCIO plus best supportive care (BSC) versus BSC alone in patients with unresectable locally advanced or metastatic UC whose disease had not progressed following first-line platinum-containing chemotherapy.1

“We are proud to advance treatment options to Canadian urothelial carcinoma patients,” says Manuel Zafra, Managing Director of EMD Serono. “This represents a significant milestone for the continued partnership between EMD Serono and Pfizer Canada ULC.”

“Our Alliance and the approval of this urothelial carcinoma indication demonstrates our commitment to meeting the needs of patients,” says Cynthia Di Lullo, Oncology Lead, Pfizer Canada ULC, “We look forward to bringing this new treatment option to a patient population who needed to see advances in science in this area of unmet need.”

For further information: Smita Devane-Bhan