AstraZeneca Pharma India announced on Tuesday that it has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its cancer treatment drug Trastuzumab Deruxtecan for an additional indication in the country.

In a statement, the company said the new approval permits the import, marketing, and distribution of Trastuzumab Deruxtecan for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours, who have previously undergone systemic therapy and have no satisfactory alternative treatment options available.

With this regulatory green light, the drug becomes the first and only antibody-drug conjugate in India with a tumour-agnostic indication, marking what the company described as a significant step forward in precision oncology.

 

“This milestone reflects our unwavering commitment to patient-centricity, scientific excellence, and equitable access to breakthrough therapies. By bringing Trastuzumab Deruxtecan to patients in India with HER2-positive solid tumours, we take a significant step forward in addressing unmet medical needs and transforming cancer care,” said Praveen Rao Akkinepally, Country President & Managing Director, AstraZeneca Pharma India.

 

The drug was already approved in India for the treatment of metastatic breast cancer—including HER2-positive, HER2-low, and HER2-ultralow subtypes—as well as locally advanced or metastatic gastric cancer.

The tumour-agnostic approval now expands its scope, potentially benefiting a broader group of patients with advanced HER2-positive cancers across various tumour types.

A tumour-agnostic label means a cancer treatment can be used regardless of where the tumour is located in the body, as long as it has a specific genetic or molecular characteristic — in this case, HER2-positive.