AstraZeneca Breast Cancer Drug Approved in India

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Dec 18, 2025 18:27

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AstraZeneca receives CDSCO approval to import & sell Datopotamab Deruxtecan for HR-positive, HER2-negative metastatic breast cancer in India.
AstraZeneca Breast Cancer Drug Approved in India
Photograph: Kind courtesy jorono/Pixabay.com
New Delhi, Dec 18 (PTI) AstraZeneca Pharma on Thursday said the Central Drugs Standard Control Organisation has granted regulatory approval to import, sell, and distribute breast cancer drug Datopotamab Deruxtecan in India.

The approval reflects the company's focus on bringing to life-changing medicines at a rapid pace and marks its second antibody–drug conjugate approval in India after trastuzumab deruxtecan, the drug firm said in a statement.


“The approval of Datopotamab Deruxtecan offers a much-needed treatment option for patients with HR-positive, HER2-negative metastatic breast cancer, potentially earlier in the treatment journey,” AstraZeneca Pharma India Country President and MD Praveen Akkinepally stated.

Breast cancer is now the most diagnosed cancer globally, with over 2.3 million cases recorded in 2022 according to the World Health Organization (WHO).

In India, the burden continues to grow rapidly, incidence rates have risen by nearly 40 per cent over the past 25 years, making breast cancer the most prevalent cancer among Indian women.
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