AstraZeneca gets regulator's nod to market cancer drug in India

AstraZeneca Pharma on Tuesday said it has received approval from the national drug regulator to market a cancer treatment drug in the country.

The company has received approval from the Central Drugs Standard Control Organisation ( CDSCO) to import, market, and distribute Trastuzumab Deruxtecan for an additional indication in India, the drug firm said in a statement.

With this approval, Trastuzumab Deruxtecan is now indicated for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumours, who have received prior systemic therapy and have no satisfactory alternative treatment options, it added.

This marks the first and only antibody drug conjugate in India with a tumour-agnostic indication, representing a significant advancement in precision oncology, the company said.

"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," AstraZeneca Pharma India Country President & MD Praveen Rao Akkinepally said.

Trastuzumab Deruxtecan is already approved in India for the treatment of metastatic breast cancer (HER2-positive, HER2-low, and HER2-ultralow) and locally advanced or metastatic gastric cancer.

The tumour-agnostic approval further broadens its potential to benefit patients across a range of advanced HER2-positive cancers.