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Abemaciclib is a CDK4/6 inhibitor which has now been approved for HR+ HER2 – node positive high risk early breast cancer.
India
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New Delhi, November 24, 2022:
Eli Lilly and Company (India) Pvt. Ltd. (“Lilly India”) has announced the launch of the additional indication for Ramiven® (abemaciclib), following approval from The Drug Controller General of India (DCGI) in combination with endocrine therapy for adjuvant treatment in adult patients with hormone receptor (HR)positive, human epidermal growth factor receptor 2(HER2) negative, node-positive early breast cancer (EBC) at high risk of recurrence.
CDK 4/6 inhibitors are a class of medicines used to treat certain types of metastatic breast cancers. In India, over 50,000 patients are diagnosed with HR+/HER2- early breast cancer (EBC) every year. Close to 30% of EBC patients with high-risk clinical or pathological features experience recurrence or metastasis despite receiving standard therapy.
Vineet Gupta, Managing Director, Eli Lilly and Company – India & India Subcontinent, said, “Breast cancer is the cancer which is most prevalent amongst women in India. It significantly impacts the quality of life of survivors and their families, who live with the fear of recurrence. The approval of Ramiven® for treatment of Early Breast Cancer brings more optimism by providing a new treatment option to the healthcare professionals for their patients.”
Ramiven® is already approved for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer. Ramiven® is a prescription drug to be used only on the advice of an oncologist and under medical supervision. It is available in tablet strengths of 200 mg, 150 mg, 100 mg, and 50 mg.
About early breast cancer (EBC)
Early breast cancer (EBC) is cancer that has not spread beyond the breast or underarm lymph nodes. The most common type of breast cancer is HR+, HER2-. Most EBC is treatable and does not return. However, there are many factors that may influence whether the breast cancer returns. 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 tumor size (≥5 cm), high tumor grade (Grade 3), and high rate of cellular proliferation [Ki-67 score (≥20%). Node-positive means that cancer cells from the tumor 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 indicate that there is a higher chance of the cancer returning and spreading.
About Ramiven®
Ramiven® (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Ramiven® is a non-chemotherapy oral tablet.
Early Breast Cancer
Ramiven® in combination with endocrine therapy is indicated for the adjuvant treatment
of adult patients with hormone receptor (HR)-positive, human epidermal growth factor
receptor 2 (HER2)-negative, node-positive early breast cancer at high risk of recurrence (see section pharmacodynamic property*)
In pre- or perimenopausal women, aromatase inhibitor endocrine therapy should be combined
with a luteinising hormone-releasing hormone (LHRH) agonist.
Advanced or Metastatic Breast Cancer
Ramiven® is indicated for the treatment of women with hormone receptor (HR) positive (HR+), human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.
- In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
As monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
Ramiven® 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.
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