AstraZeneca Pharma's Cancer-Treating Drug Gets Regulator's Approval In India

AstraZeneca Pharma India Ltd announced on Wednesday that the cancer medicine trastuzumab deruxtecan has been approved by the medicine Controller General of India (DCGI) for the treatment of metastatic breast cancer. The company said that it has received approval to import and market trastuzumab deruxtecan, which is used in the treatment of certain "HER-2 positive" breast cancers.

"The India approval is based on the global, head-to-head, randomised, open label, registrational Phase III DESTINY Breast 03 trial." According to AstraZeneca Pharma India, trastuzumab deruxtecan is approved in more than 40 countries, including the United States, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. HER2 is a type of growth-promoting protein found on the surface of many tumours, including breast, gastric, lung, and colorectal cancers, and is one of the biomarkers found in breast cancer tumours, according to the study. "India's approval of trastuzumab deruxtecan marks a significant clinical advancement, allowing us to help more patients across the HER2 spectrum," said Sanjeev Panchal, Country President and Managing Director of AstraZeneca India.