Astrazneca Pharma India has received approval to expand the use of a breast cancer treatment from India’s drug regulator that can bring new hope for many women with advanced disease.

The drug, trastuzumab deruxtecan, was already available for some breast and stomach cancer.

Now, it has been approved to treat more patients, especially Her2-Low or Her2-Ultralow Metastatic breast cancer. Adults have already tried hormone-based treatment.

This approval of the Central Drugs Standard Control Organization (CDSCO) means that more patients in India as well as patients with hard-to-treat breast cancer can use medication.

Her2-Low What is breast cancer?

Her2 is a protein found on the surface of some cancer cells. When Her2 levels are high, some targeted treatment may work. However, many patients have less or very low levels of this protein, these are known as Her2-Low or Her2-Utralow cancer.

Until some time ago, there were limited treatment options for these patients. But this drug also provides a target approach in people with low HER2 levels.

Science behind approval

The decision is based on the results of a large international study called Destiny-Breast 06, which compared Treestuzumab Dethxtekan with standard chemotherapy.

The test included patients who had already received at least one hormone therapy, but there was no chemotherapy for their metastatic cancer.

The results were promising:

• Patients who took Testuzumab Deruxtekan lived for a long time without getting worse.
• Her2-Low For people with breast cancer, the average time without the progression of the disease was 13.2 months, compared to 8.1 months for those on chemotherapy.
• The risk of disease progression or death was reduced by about 40%.

Director of Medical Affairs at Astrajeneka India, Dr. Sandeep Arora said, “This approval marks a change in treating advanced breast cancer in India. It highlights the importance of tumor testing for minimal Her2 expression to identify patients that may benefit.”

Why does it matter in India

According to the World Health Organization, with more than 2 million cases in 2020, breast cancer is the world’s most diagnosed cancer. In India, the number of breast cancer cases has increased by 40% in the last 25 years.

Astrajeneka India Managing Director Dr. Sanjeev Panchal called it part of a comprehensive effort to “follow science” and provide better, more personal cancer care.

The drug was first introduced in India in 2024 and is now approved for three types of breast and gastric cancer. Experts hope that with widespread use, this drug can significantly improve the survival rate for women with advanced breast cancer.

Doctors say that it will now be important to test the tumor for Her2 expression, even at very low levels, to identify who can benefit from this treatment.

There is not a cure, trastuzumab deruxtecan represents another important step in making the treatment of breast cancer more accurate and more effective for Indian patients.