Eli Lilly introduces Ramiven® (abemaciclib) in India, for certain high-risk early breast cancer patients

November 24, 2022

Abemaciclib is a CDK4/6 inhibitor which has now been approved for HR+ HER2 – node positive high risk early breast cancer.

India

healthysoch

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.

healthysoch

Stay informed with the latest news from HealthySoch. Sign up today for exclusive insights and updates!

We promise we never spam!

Leave a Reply

Your email address will not be published.

Health Tips

Dr. T S Kler Padma Bhushan Awardee
MD, DM, MRCP, FRCP(U.K), FACC, D.Sc
Chairman – Fortis Heart Institute Gurugram

Precautions to avoid Corona Virus:

  1. Stay home as far as possible.
  2. Wash hands with soap and water frequently.
  3. Keep distance from people even your home members.
  4. Keep atleast 1-2 metres away from anybody coughing.
  5. Don’t touch your face, nose and mouth.

 

Dr. K.K Says

Archives

MonTueWedThuFriSatSun
    123
45678910
18192021222324
25262728293031
       
   1234
567891011
12131415161718
26272829   
       
891011121314
293031    
       
    123
45678910
11121314151617
25262728293031
       
  12345
6789101112
13141516171819
27282930   
       
      1
2345678
9101112131415
16171819202122
3031     
     12
17181920212223
24252627282930
31      
   1234
567891011
12131415161718
2627282930  
       
1234567
891011121314
22232425262728
293031    
       
     12
3456789
17181920212223
24252627282930
       
  12345
6789101112
       
  12345
13141516171819
2728     
       
      1
9101112131415
3031     
   1234
567891011
       
282930    
       
    123
45678910
       
  12345
27282930   
       
      1
3031     
    123
11121314151617
       
28      
       
2930     
       
    123
       
       
       
      1
9101112131415
3031     
     12
3456789
10111213141516
17181920212223
242526272829 
       
  12345
13141516171819
2728293031  
       
      1
23242526272829
3031     
    123
       
    123
25262728   
       
78910111213
28293031   
       
293031    
       
14151617181920
28293031   
       
   1234
567891011
       
   1234
567891011
262728    
       
891011121314
293031    
       
    123
18192021222324
25262728293031
       
  12345
27282930   
       
      1
2345678
16171819202122
3031     
    123
45678910
18192021222324
       
28293031   
       
     12
31      
   1234
       
  12345
6789101112
       
HealthySoch

Don't Miss

Healthspring to Test for Antibodies for COVID-19

India healthysoch Bangalore, India, July 02, 2020: Healthspring, leaders in

53-year-old Patient with Osteoarthritis undergoes Live Surgery at Manipal Hospital

India healthysoch Pune/ Chandigarh, December 26, 2023:  Doctors at Manipal