DCGI okays AstraZeneca's breast cancer drug Trastuzumab deruxtecan
The HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumours including breast, gastric, lung and colorectal cancers, and is one of the biomarkers expressed in breast cancer tumours.;
New Delhi: AstraZeneca Pharma India Ltd., a science-led biopharmaceutical company, has announced that it has received approval from the Drug Controller General of India (DCGI) for the cancer drug Trastuzumab Deruxtecan for the treatment of metastatic breast cancer.
AstraZeneca has received import and marketing permission in Form CT-20 from the regulator, and the therapy is indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen.
The India approval is based on a global, head-to-head, randomised, open-label, registrational Phase III trial of DESTINY Breast 03. Globally, Trastuzumab Deruxtecan is approved in more than 40 countries, including the US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
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