AstraZeneca Pharma India Ltd said on Wednesday it has received approval from the Controller General of Medicines of India (DCGI) for the cancer drug trastuzumab deruxtecan for the treatment of metastatic breast cancer.
The company said it has received approval to import and market trastuzumab deruxtecan used in the treatment of selected “HER-2 positive” breast cancer.
“India’s approval is based on an open-label, randomized, head-to-head, global registry Phase III trial, 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,” AstraZeneca Pharma India said in a statement.
HER2 is a form of growth-promoting protein expressed on the surface of multiple tumors, including breast, gastric, lung, and colorectal cancers, and is one of the biomarkers expressed in breast cancer tumors, he added.
“The approval of trastuzumab deruxtecan in India marks a significant clinical breakthrough that allows us to help more patients across the HER2 spectrum,” said AstraZeneca India President and CEO Sanjeev Panchal.
(Only the headline and image in this report may have been modified by Business Standard staff; all other content is auto-generated from a syndicated feed.)
First posted: 03 May 2023 | 21:49 IS
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