With breast cancer cases on the rise in India, a new treatment option has emerged as AstraZeneca secures approval for broader use of Trastuzumab deruxtecan.

AstraZeneca Pharma India has received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and sell Trastuzumab deruxtecan (100 mg), a medicine used for treating certain types of breast cancer. This approval allows the drug to be used for a new group of patients in India.

The medicine can now be used as a single treatment (monotherapy) for adults with HER2-low or HER2-ultralow breast cancer that cannot be removed by surgery or has spread (metastatic) as per AstraZeneca’s report. These patients must have already received at least one hormonal therapy in the metastatic stage.

Breast cancer is the most commonly diagnosed cancer in the world, with over 2.3 million cases reported in 2022, according to the World Health Organization (WHO). In India, breast cancer cases have increased by 40% in the last 25 years. This drug offers new hope to patients with HER2-directed metastatic breast cancer.

Dr. Sandeep Arora, Director of Medical Affairs at AstraZeneca India, said, “This approval is based on the results of the DESTINY-Breast06 trial. It opens a new way to test and treat metastatic breast cancer in India. Testing for any level of HER2 protein in tumors is now important to identify patients who can benefit from this treatment after one hormonal therapy.”

Trastuzumab deruxtecan is a type of medicine called an antibody-drug conjugate (ADC). It was first launched in India in 2024 and is already approved for use in breast and stomach cancers. It has shown promising results in helping patients live longer.

In the DESTINY-Breast06 trial, researchers compared Trastuzumab deruxtecan with the doctor’s choice of chemotherapy in patients with hormone receptor-positive, HER2-low or HER2-ultralow metastatic breast cancer. The patients had not received chemotherapy before in the metastatic stage but had taken hormonal therapies.

The results showed that patients who received Trastuzumab deruxtecan lived longer without their cancer getting worse. In the HER2-low group, the average time before the cancer worsened was 13.2 months with Trastuzumab deruxtecan, compared to 8.1 months with regular chemotherapy.

This new approval could make a big difference in treating more breast cancer patients effectively in India.