AstraZeneca Pharma India Ltd has announced that it has received approval from the Drug Controller General of India (DCGI) for the cancer drug trastuzumab deruxtecan, used for the treatment of metastatic breast cancer. The drug is approved in over 40 countries, including the US, and has been granted approval in India based on a Phase III trial, DESTINY Breast 03. Trastuzumab deruxtecan is used for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. AstraZeneca India Country President and Managing Director Sanjeev Panchal has called the approval a “significant clinical advancement” for helping more patients across the HER2 spectrum.
Trastuzumab deruxtecan is a cancer drug used in the treatment of select HER2-positive breast cancer. The recent approval by the Drug Controller General of India (DCGI) for AstraZeneca Pharma India Ltd. to import and market the drug in India is based on a global, head-to-head, randomized, open-label, registrational Phase III trial DESTINY Breast 03. The drug has already been approved in more than 40 countries worldwide, including the US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. This approval marks a significant advancement in clinical treatment for HER2-positive breast cancer patients in India.
