VERZENIO (abemaciclib) Available in Canada for Metastatic Breast Cancer
TORONTO, Aug. 8, 2019 /CNW/ - Eli Lilly Canada Inc. (Lilly Canada) is pleased to announce the availability of VERZENIO™ (abemaciclib). VERZENIO is indicated for the treatment of estrogen and/or progesterone hormone receptor positive (HR+) and human epidermal growth factor 2 negative (HER2-) metastatic breast cancer (mBC): in combination with an aromatase inhibitor for postmenopausal women as initial endocrine-based therapy; in combination with fulvestrant for women with disease progression following endocrine therapy; and as a single agent for women with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
VERZENIO is a cyclin-dependent kinase (CDK) 4 & 6 inhibitor1. The recommended dose of VERZENIO in combination with endocrine therapy (i.e. anastrozole, letrozole, fulvestrant) is 150 mg orally twice daily, and as monotherapy is 200 mg, continued until disease progression or unacceptable toxicity. VERZENIO is available in four tablet strengths (200 mg, 150 mg, 100 mg, and 50 mg)2.
"When a new medication is approved to effectively treat breast cancer, it brings additional options to Canadian women living with metastatic breast cancer", says Cathy Ammendolea, Chair of the Board of Directors for the Canadian Breast Cancer Network (CBCN). "Having more treatment options for women living with advanced breast cancer means we continue to move in a direction that may enable these women to live their lives to the fullest."
"Targeted therapies like abemaciclib, may help patients whose breast cancer presents with certain disease characteristics that confer a less favorable prognosis," says Dr. Christine Brezden-Masley, Medical Oncologist, Medical Director of Cancer Services, Mount Sinai Hospital in Toronto, Ontario. "Because breast cancers are as diverse as the women who have them, and advanced disease can be a labyrinth of tumour sites and presentation, mBC remains a challenging disease to treat. By disrupting the pathway that leads cancer cells to grow and divide, abemaciclib either alone, or in combination with endocrine therapy, can manage metastatic disease for some by delaying disease progression."
The research behind VERZENIO - MONARCH 3, MONARCH 2 and MONARCH 13
About MONARCH 3
If neoadjuvant/adjuvant endocrine therapy was administered, a disease-free interval of more than 12 months since completion of endocrine therapy was required. A total of 493 patients were randomized 2:1 to receive 150 mg of VERZENIO or placebo orally twice a day, without interruption, given in combination with either 1 mg of anastrozole or 2.5 mg of letrozole once daily until disease progression or unacceptable toxicity. The primary endpoint of the study was progression-free survival (PFS), with key secondary endpoints of overall response rates (ORR), duration of response (DoR), overall survival (OS) and safety4.
About MONARCH 2
About MONARCH 1
The most frequently reported (>5%) Grade 3 or Grade 4 adverse reactions across the three studies were: neutropenia, diarrhea, leukopenia, anemia and increases in alanine aminotransferase (ALT).
The tumour's HR and HER2 status determine sub-types of mBC8. The most common type is HR+ and HER2-, which occurs in about 70 per cent of breast cancer cases9. Despite improvements made with early detection and treatment, there is currently no cure for mBC. The five-year relative survival rate is 22 per cent for women with advanced breast cancer or mBC in Canada10.
About VERZENIO™ (abemaciclib)
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 tumor 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 concentrations3.
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.
VERZENIO is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer:
Clinical effectiveness of VERZENIO in combination with an aromatase inhibitor is based on the benefit observed in patients treated with VERZENIO in combination with letrozole or anastrozole for the treatment of postmenopausal women with advanced breast cancer.
The full VERZENIO Product Monograph is available here.
About Eli Lilly Canada Inc.
Eli Lilly Canada 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. Our work focuses on oncology, diabetes, autoimmunity, neurodegeneration, and pain. To learn more about Eli Lilly Canada, please visit us at www.lilly.ca.
VERZENIOTM registered trademark owned by Eli Lilly and Company; used under license.
SOURCE Eli Lilly Canada Inc.