Lilly Canada and the pan-Canadian Pharmaceutical Alliance (pCPA) Successfully Complete Negotiations for Verzenio® (abemaciclib) in Expanded Early Breast Cancer (EBC) Indication

TORONTO, Oct. 29, 2024 /CNW/ - Eli Lilly Canada Inc. ("Lilly") is pleased to announce that it received a positive Canada's Drug Agency (CDA-AMC, formally known as CADTH) recommendation for the Verzenio® (abemaciclib) expanded indication in early breast cancer (EBC) for the full intention-to-treat (ITT) population. Subsequently, Lilly and the pan-Canadian Pharmaceutical Alliance (pCPA) successfully concluded the negotiations for Verzenio's expanded indication on October 25^th, 2024. This milestone represents a significant advancement in our ongoing commitment to providing innovative treatment options for EBC patients in Canada who have been diagnosed with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, EBC at high risk of disease recurrence based on certain clinicopathological features.

"This expanded access is welcome news for those in the breast cancer community", said MJ DeCoteau, Founder and Executive Director of Rethink Breast Cancer. "Reducing the risk of recurrence is an important priority for patients diagnosed with early-stage breast cancer, especially for those diagnosed at a younger age, which we see often in the Rethink community. Making treatments accessible that have proven efficacy in reducing risk of recurrence is incredibly valuable to patients and their families. We are pleased with this positive recommendation from CDA-AMC, and the successful conclusion of negotiations with the pCPA."

"We are pleased to hear about the positive recommendation from Canada's Drug Agency and the subsequent completion of negotiations for Verzenio's expanded indication. Verzenio represents an important advancement in the treatment options for breast cancer patients," said Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network (CBCN). "It's encouraging to see how quickly all parties have worked together to ensure patients have access to this expanded indication. We are pleased to hear this news and look forward to the jurisdictional listings to come."

Verzenio® is indicated in combination with endocrine therapy (ET), for the adjuvant treatment of adult patients with HR+, HER2-, node-positive, EBC at high risk of disease recurrence based on clinicopathological features, as defined by the presence of four or more positive nodes, or one to three positive nodes and at least one of the following: a tumour of ≥5 cm, histological grade 3 disease, or Ki-67 score ≥20%. This indication represents a broader population of patients than what was initially approved by Health Canada for EBC in 2022.

"We are thrilled to have CDA-AMC recommended reimbursement of Verzenio for the expanded EBC full ITT indication, and to subsequently conclude negotiations with pCPA successfully. This marks a crucial step forward in making Verzenio accessible to more Canadians with breast cancer," said Dr. Kenneth Custer, General Manager of Lilly Canada. "This recommendation, and the subsequent conclusion of negotiations, reflects our dedication to improving patient outcomes and reinforces our commitment to advancing cancer care."

About Early Breast Cancer and Risk of Recurrence 

It is estimated that 90 percent of all breast cancers are detected at an early stage. Approximately 70 per cent of all breast cancers are of the HR+ HER2- subtype. Although the prognosis for HR+ HER2- EBC is generally positive, 20 per cent of patients will experience recurrence potentially to incurable metastatic disease. Risk of recurrence is greatest within the initial two to three years post-diagnosis, particularly in patients with node-positive, high risk EBC. Factors associated with high risk of recurrence include: positive nodal status, large tumour size (≥5 cm), high tumour grade (Grade 3), and high rate of cellular proliferation [Ki-67 score (≥20%)].

Node-positive means that cancer cells from the tumour in the breast have been found in the lymph nodes in the armpit area. Although the breast cancer is removed through surgery, the presence of cancer cells in the lymph nodes signifies that there is a higher chance of the cancer returning and spreading.

About Breast Cancer 

Breast cancer has now surpassed lung cancer as the most diagnosed cancer worldwide, according to GLOBOCAN. In the report, breast cancer had an age standardized rate (ASR) of 82.1 per 100,000, which means that about 1 in every 8 of new Canadian cancer diagnosis in 2020 was breast cancer. With approximately 685,000 deaths in 2020, breast cancer is the fifth-leading cause of cancer death worldwide.⁵ In Canada, it is estimated that 29,400 Canadian women will have been diagnosed with breast cancer, by the end of 2023. This represents 26% of all new cancer cases in women in 2023.

About Verzenio^® (abemaciclib)

Verzenio^® abemaciclib is a targeted treatment known as a CDK4/6 inhibitor. Verzenio is a non-chemotherapy oral tablet.

Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells, so they may eventually die (based on preclinical studies). Cyclin-dependent kinases (CDK)4/6 are activated by binding to D-cyclins. In estrogen receptor-positive (ER+) breast cancer cell lines, cyclin D1 and CDK4/6 promote phosphorylation of the retinoblastoma protein (Rb), cell cycle progression, and cell proliferation.

In vitro, continuous exposure to Verzenio inhibited Rb phosphorylation and blocked progression from G1 to S phase of the cell cycle, resulting in senescence and apoptosis (cell death). Preclinically, Verzenio dosed daily without interruption resulted in reduction of tumour size. Inhibiting CDK4/6 in healthy cells can result in side effects, some of which may be serious. Clinical evidence also suggests that Verzenio crosses the blood-brain barrier. In patients with advanced cancer, including breast cancer, concentrations of Verzenio and its active metabolites (M2 and M20) in cerebrospinal fluid are comparable to unbound plasma concentrations.

Verzenio is Lilly's first solid oral dosage form to be made using a faster, more efficient process known as continuous manufacturing. Continuous manufacturing is a new and advanced type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.

About Lilly Canada

Lilly is a medicine company turning science into healing to make life better for people around the world. Lilly has been pioneering life-changing discoveries for nearly 150 years, and today our medicines help more than 51 million people across the globe. Lilly's Canadian Affiliate, Eli Lilly Canada Inc. was established in 1938, the result of a research collaboration with scientists at the University of Toronto which eventually produced the world's first commercially available insulin.

Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable.

To learn more about Lilly Canada, visit www.lilly.com/en-CA, or follow us on LinkedIn.

SOURCE Eli Lilly Canada Inc.

For more information, please contact: Amanda Meek, Eli Lilly Canada Inc., [email protected]