Pfizer Canada announced that Health Canada has provided conditional approval of Ibrance (palbociclib) and it is now available in Canada.
Ibrance is a kinase inhibitor indicated in combination with letrozole for the treatment of postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
When Terry Playfair, a 66-year old grandmother of five, was diagnosed with ER-positive, HER2-negative metastatic breast cancer (mBC), she was left feeling discouraged and without hope.
“It was extremely difficult to learn that I was living with an incurable disease that would likely leave me with only a few years left to spend with my family and friends,” says Terry Playfair. “When I was diagnosed, my doctor enrolled me in an Ibrance clinical trial. I was excited to have the opportunity to try a new option and am pleased that it’s now available to more women like me who are living with metastatic breast cancer.”
Terry is not alone in her fight against mBC. In fact, approximately 5-10 per cent of newly diagnosed breast cancers are metastatic and about 20-30 per cent of women first diagnosed with early stage breast cancer will go on to develop mBC in their lifetime.
“As someone who works with women who are living with metastatic breast cancer, and having personally experienced a breast cancer diagnosis, I understand the valuable role that new medicines play in the treatment of this disease,” says Cathy Ammendolea, Chair of the Board of Directors, Canadian Breast Cancer Network. “Women living with mBC simply don’t have the luxury of time to wait for access to new medicines.”
“While public awareness of early breast cancer has risen, there are still many misconceptions about metastatic disease which can leave patients feeling isolated and without hope,” says MJ DeCoteau, founder and executive director, Rethink Breast Cancer. “We need to raise the volume on the conversation about mBC and spread the message that while this is an incurable form of cancer, new therapies are helping women live longer with a good quality of life.”
Despite improvements made with early detection and treatment, there is no cure for mBC, demonstrating a need for further investment and research in this area.
“Fewer than one in four women diagnosed with metastatic breast cancer will live beyond five years which is a stark contrast to early stage breast cancer, where nine in 10 patients will survive for more than five years,” says Dr. John Mackey, medical oncologist and professor at the University of Alberta, and director at Translational Research In Oncology (TRIO), a not-for profit academic clinical research organisation (CRO). “Today’s announcement is exciting as it gives women across Canada living with advanced breast cancer a new treatment option for this incurable but treatable disease.”
Ibrance provides patients with a new therapeutic option, while raising awareness and inspiring conversations about this often misunderstood and difficult disease.
“Pfizer Canada understands the significant challenges associated with treating metastatic breast cancer,” says Craig Eagle, general manager, Pfizer Oncology Canada. “We are proud that Ibrance is the first medicine in a new class of anti-cancer agents, CDK 4/6 inhibitors, to be approved in Canada for HER2-negative, ER-positive metastatic breast cancer.”
The Health Canada approval of Ibrance is based on the final results of the phase 2 PALOMA-1/TRIO 18 trial (n=165), which studied whether Ibrance in combination with letrozole prolonged progression-free survival (PFS) compared with letrozole alone in postmenopausal women with ER-positive, HER2-negative locally advanced or mBC who had not received previous systemic treatment for their advanced disease. The Health Canada approval of Ibrance is contingent upon verification and description of clinical benefit in a confirmatory trial.
Ibrance has been studied extensively in Canada for use in mBC. In fact, 114 patients at more than 27 Canadian centres have participated in clinical trials to date. Participation in other Canadian clinical trials will continue on an ongoing basis.
Pfizer also ran a Canadian Expanded Access Program clinical trial prior to the approval of Ibrance for postmenopausal women with ER-positive, HER2-negative advanced breast cancer who were deemed appropriate for letrozole therapy. The trial included nine Canadian centres.