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HEALTH CANADA APPROVES BAVENCIO® FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH ADVANCED BLADDER CANCER

22/01/21

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

Jan. 22, 2021 – MISSISSAUGA, ONTARIO – 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.”

About Urothelial Carcinoma in Canada
Bladder cancer is the fifth most common cancer in Canada. In 2019, approximately 11,800 individuals were diagnosed and an estimated 2,500 died from bladder cancer.2 Bladder cancer has a recurrence rate of 60-70 per cent in patients.

About BAVENCIO® (avelumab)
BAVENCIO is a human anti-programmed death ligand-1 (PD-L1) antibody and is part of a class of immunotherapy drugs called immune checkpoint inhibitors. BAVENCIO was discovered by Merck KGaA, Darmstadt, Germany and is co-developed and co-commercialized by EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany in the US and Canada, and Pfizer Canada ULC. BAVENCIO is also indicated for the treatment of adult patients with metastatic Merkel cell carcinoma (MCC) and for the treatment of patients with locally advanced or metastatic UC who have disease progression during or following platinum-based chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-based chemotherapy.

About EMD Serono, Canada
EMD Serono, Canada, is the Canadian biopharmaceutical business of Merck KGaA, Darmstadt, Germany. EMD Serono, Canada has integrated cutting-edge science, innovative products and devices, and industry-leading patient support and access programs. EMD Serono, Canada has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in neurology, oncology, immunology and immuno-oncology. EMD Serono, Canada has more than 100 employees across Canada with headquarters in Mississauga, Ontario.

About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live.

From advancing gene editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany, generated sales of € 16.2 billion in 66 countries.

The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company.

About Pfizer Canada
Pfizer Canada ULC is the Canadian operation of Pfizer Inc., one of the world's leading biopharmaceutical companies. Our diversified health care portfolio includes some of the world's best known and most prescribed medicines and vaccines. We apply science and our global resources to improve the health and well-being of Canadians at every stage of life. Our commitment is reflected in everything we do, from our disease awareness initiatives to our community partnerships. To learn more about Pfizer Canada, visit  pfizer.ca or you can follow us on LinkedIn, Facebook, Twitter or YouTube.

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For further information:

Karley Ura
Director, Healthcare, NATIONAL Public Relations
416-858-0537
[email protected]

Smita Devane-Bhan
Head of Communications, EMD Serono
905-919-0245
[email protected]

Sophie Morin
Manager, Corporate Affairs, Pfizer Canada
1-866-9PFIZER (1-866-973-4937)
[email protected]

[1] BAVENCIO Product Monograph. EMD Serono Inc. And Pfizer Canada ULC; 2020.
[1] Canadian Cancer Society. Canadian Cancer Statistics 2019. Https://www.cancer.ca/~/media/cancer.ca/CW/cancer%20information/cancer%20101/Canadian%20cancer%20statistics/Canadian-Cancer-Statistics-2019-EN.pdf?la=en. Accessed November 2020.
[1] Bladder Cancer Facts. Bladder Cancer Canada. https://bladdercancercanada.org/en/bladder-cancer-facts/. Accessed November 2020.