Eli Lilly and Company (India) Pvt. Ltd. (“Lilly India”) has announce 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 use to treat certain types of metastatic breast cancers.
In India, over 50,000 patients are diagnose 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 :
Ramiven® is already approve for the treatment of certain types of HR+ HER2- advance or metastatic breast cancer.
Ramiven® is a prescription drug to be use 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 associate 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 found in the lymph nodes in the armpit area.
Although the breast cancer is remove through surgery, the presence of cancer cells in the lymph nodes indicate that there is a higher chance of the cancer returning and spreading.
Ramiven® (abemaciclib) is a target treatment known as a CDK4/6 inhibitor.
Ramiven® is a non-chemotherapy oral tablet.
Early Breast Cancer
Ramiven® in combination with endocrine therapy is indicate 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 combine with a luteinising hormone-releasing hormone (LHRH) agonist.
Advanced or Metastatic Breast Cancer
Ramiven® is indicate 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 receive 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 advance 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 advance type of manufacturing within the pharmaceutical industry, and Lilly is one of the first companies to use this technology.
Please refer to full prescribing information* for Ramiven®Prescribing Information about Ramiven® (abemaciclib) can be found here
About Eli Lilly and Company
Lilly is a global health care leader that unites caring with discovery to create medicines that make life better for people around the world.
We were find more than a century ago by a man commit to creating high-quality medicines that meet real needs, and today we remain true to that mission in all our work.
Across the globe, Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.
About Eli Lilly India
Eli Lilly and Company (India) Pvt. Ltd. (Lilly India), headquarter in Gurgaon, is a wholly own subsidiary of Eli Lilly and Company, a global biopharmaceutical company headquartered in Indianapolis, USA.
Since its inception more than 25 years ago, Lilly India has committed to offer advance treatment options to treat chronic diseases such as diabetes, lung cancer, gastric cancer, osteoporosis, rheumatoid arthritis, men’s health, and growth-hormone deficiency.