AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) to import and market Trastuzumab Deruxtecan in India for an expanded indication. This latest approval allows use in adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumours who have undergone prior systemic therapy and have no satisfactory alternative treatment options.
Trastuzumab Deruxtecan becomes the first and only antibody drug conjugate (ADC) in India approved with a tumour-agnostic indication. This milestone represents a breakthrough in precision oncology, addressing HER2 overexpression in multiple solid tumours, including breast, gastric, biliary tract, bladder, pancreatic, and gynaecological cancers. These cancers often exhibit aggressive behaviour and limited benefit from conventional chemotherapy, especially after progression on standard treatments.
The CDSCO approval is backed by data from three major global studies -DESTINY-PanTumor02, DESTINY-Lung01, and DESTINY-CRC02. Across 192 adult patients with HER2-positive solid tumours, the confirmed objective response rates (ORR) were 51.4%, 52.9%, and 46.9% respectively. Durable responses were seen across tumour types, with median progression-free survival (PFS) of 11.9 months, 6.7 months, and 5.8 months, indicating substantial clinical benefit.
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Trastuzumab Deruxtecan is already approved in India for HER2-positive, HER2-low, and HER2-ultralow metastatic breast cancer, as well as locally advanced or metastatic gastric cancer. This expanded use significantly broadens its reach, offering new hope to patients with difficult-to-treat cancers beyond traditional settings. The approval aligns with AstraZeneca's mission to drive science-led innovation and patient-centric care.
AstraZeneca Pharma India emphasised its commitment to equitable access and innovative cancer care. With 98.8 million digital touchpoints globally and a growing offline presence, the company continues to integrate research, development, and patient outreach to transform oncology in India. This approval sets a new precedent in treating HER2-driven tumours with targeted, tumour-agnostic therapies.
On October 7, 2025, AstraZeneca Pharma India share price opened at ₹9,370.00 on NSE, below the previous close of ₹9,414.50. During the day, it surged to ₹9,421.50 and dipped to ₹9,351.00. The stock is trading at ₹9,389.50 as of 2:49 PM. The stock registered a marginal change of -0.27%.
Over the past week, it has moved up by 1.82%, over the past month, it has moved up by 3.18%, and over the past 3 months, it has moved up by 2.96%.
The CDSCO’s approval of Trastuzumab Deruxtecan for HER2-positive solid tumours marks a major advancement in oncology treatment in India. As the country’s first tumour-agnostic ADC, it offers a vital lifeline for patients lacking further options and underscores AstraZeneca’s leadership in precision oncology and commitment to innovation-driven cancer care.
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Published on: Oct 7, 2025, 4:48 PM IST
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