Eli Lilly unveils DCGI approved Ramiven in India for early stage breast cancer
Ramiven (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor.
New Delhi: Eli Lilly and Company (India) Pvt. Ltd. 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.
Ramiven (abemaciclib) is a targeted treatment known as a CDK4/6 inhibitor. Ramiven is a non-chemotherapy oral tablet.
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 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 150 mg, 100 mg, and 50 mg for 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[3]. 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.
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