AstraZeneca receives CDSCO's approval 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.