AstraZeneca Pharma India Ltd. on Wednesday said it has received an approval from the Drug Controller General of India for the cancer drug trastuzumab deruxtecan for treatment of metastatic breast cancer.
The company said it has been granted approval to import and market trastuzumab deruxtecan used in the treatment of select 'HER-2 positive' breast cancer.
"The India approval is based on a global, head-to-head, randomised, open label, registrational Phase III trial DESTINY Breast 03. Globally, trastuzumab deruxtecan is approved in more than 40 countries, including the U.S., for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer", AstraZeneca Pharma India said in a statement.
HER2 is a form of 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, it added.
"India's approval of trastuzumab deruxtecan marks a significant clinical advancement allowing us to help more patients across the HER2 spectrum", AstraZeneca India Country President and Managing Director Sanjeev Panchal said.
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