Science & TechnologyImportant2025-12-17

CDSCO Approves Targeted Breast Cancer Drug Dato-DXd

In News

What Happened

On December 17, 2025, AstraZeneca Pharma India received approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market Datopotamab Deruxtecan (Dato-DXd) under the brand name Datverzo. The novel antibody-drug conjugate is approved for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer.

Why It Matters

Breast cancer is the most prevalent cancer among Indian women, with many diagnosed at advanced stages. This approval introduces a highly targeted, precision medicine option for patients who have exhausted standard endocrine and chemotherapy treatments, improving survival outcomes with potentially fewer systemic side effects.

Background

History & Context

Patients with advanced HR-positive, HER2-negative breast cancer traditionally rely on endocrine therapy followed by standard chemotherapy, which often yields limited outcomes once the disease progresses. Datopotamab deruxtecan was jointly developed by AstraZeneca and Daiichi Sankyo as a precision alternative. Its approval in India was supported by the Phase 3 TROPION-Breast01 clinical trial, which demonstrated a 37 percent reduction in the risk of disease progression or death compared to standard chemotherapy.

What Changed

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BEFORE: Metastatic HR-positive, HER2-negative breast cancer patients who exhausted endocrine therapies had to rely primarily on conventional systemic chemotherapy, which causes broad cellular toxicity. NOW: Patients have access to Dato-DXd (Datverzo), a targeted antibody-drug conjugate that selectively delivers a potent topoisomerase I inhibitor directly to TROP2-expressing tumor cells.
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BEFORE: AstraZeneca had only one approved antibody-drug conjugate in India (trastuzumab deruxtecan) for breast cancer. NOW: Dato-DXd marks the second approved ADC in India for the company, expanding the precision oncology portfolio for a different molecular subtype of breast cancer.

Prelims Angle

NCERT Connection

This development is a direct application of concepts from NCERT Class 12 Biology Chapter 12 (Biotechnology and its Applications). The drug utilizes recombinant DNA technology to create a humanized monoclonal antibody that specifically targets the TROP2 antigen on cancer cells, demonstrating the clinical use of biotechnology in targeted healthcare.

Practice Questions

Q1

Correct Statement(s)

Consider the following statements regarding Datopotamab Deruxtecan (Dato-DXd): 1. It is an antibody-drug conjugate (ADC) that specifically targets the TROP2 antigen found on the surface of certain cancer cells. 2. It delivers a topoisomerase I inhibitor payload to destroy tumor cells while minimizing damage to healthy tissues. Which of the statements given above is/are correct?

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