INDIA —Eli Lilly and Company (India) Pvt. Ltd. has announced the introduction of the new indication for Ramiven (abemaciclib), a product to treat early stage breast cancer following approval from The Drug Controller General of India (DCGI).

Ramiven is to be used in combination with endocrine therapy for adjuvant treatment in adult patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, and node-positive early breast cancer (EBC) at high risk of recurrence, the company said.

Early-stage breast cancer is typically treated with tumor removal surgery, either a lumpectomy or a mastectomy. Lymph nodes near the breast can be removed during surgery to check for cancer.

Abemaciclib works by slowing or stopping the growth of cancer cells. It belongs to a class of drugs known as kinase inhibitors.

Every year, more than 50,000 patients in India are given the diagnosis of HR+/HER2-Early Breast Cancer (EBC).

Despite undergoing standard care, over 30% of EBC patients with high-risk clinical or pathological characteristics develop recurrence or metastasis.

Ramiven is already approved for the treatment of certain types of HR+ HER2- advanced or metastatic breast cancer.

It 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, the statement concluded.

One in eight women will be diagnosed with breast cancer in their lifetime – the second leading cause of cancer death for women, behind lung cancer.

In 2020, there were about 2.3 million new cases of breast cancer globally and about 685, 000 deaths from this disease, with large geographical variations observed between countries and world regions.

Research shows that increasing numbers of individuals diagnosed with early-stage breast cancer treated with systemic therapies like chemotherapy or targeted therapy achieve a “complete response” prior to breast-removal surgery.

A 2016 review of research notes that over 60% of people with triple-negative breast cancer and human epidermal growth factor receptor 2- (HER2) positive breast cancer have a complete response to neoadjuvant systemic therapy (NST), a type of cancer therapy that’s given prior to surgery.

The FDA has approved a treatment called Enhertu for metastatic HER2 low breast cancers that cannot be surgically removed.

Outside breast cancer, Enhertu in August became the first drug specifically approved for HER2-mutant non-small cell lung cancer.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.