AstraZeneca Pharma India has received approval from the Drug Controller General of India (DCGI) to import the cancer drug trastuzumab deruxtecan used for the treatment of metastatic breast cancer.

Trastuzumab deruxtecan is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The company 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.

“India’s approval of trastuzumab deruxtecan marks a significant clinical advancement, allowing us to help more patients across the HER2 spectrum. It also supports our ambition to evolve the way breast cancer is classified and treated in the country, ultimately improving patient outcomes, “ said Sanjeev Panchal, Country President and Managing Director, AstraZeneca India.

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According to the company, 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 US, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.

“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,” it added.

Trastuzumab deruxtecan has demonstrated significantly improved overall survival and progression-free survival outcomes in patients with HER2-positive metastatic breast cancer in the DESTINY Breast 03 trial. Its potential is also being explored for different types of breast cancer.

According to the World Health Organisation, more than 2 million cases of breast cancer were diagnosed in 2020, making it the world’s most commonly diagnosed cancer. The incidence of breast cancer is low in India, but it is gradually rising, with almost a 40% increase in cases, over the past 25 years.

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Survival of breast cancer for at least 5 years after diagnosis ranges from more than 90 per cent in high-income countries, to 66 per cent in India and 40 per cent in South Africa. Early detection and treatment have proven successful in high-income countries and should be applied in countries with limited resources, Anil Kukreja, Vice-President, Medical Affairs and Regulatory, AstraZeneca India, explained.

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