News ArticleAstraZeneca Pharma India Limited to Launch Datverzo in India for HR+/HER2- Metastatic Breast Cancer in November 2026
The drug is approved for adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer after prior endocrine and chemotherapy treatments
AstraZeneca Pharma India Limited announced the launch of Datopotamab Deruxtecan, branded as Datverzo, in India in November 2026. Datverzo is approved for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer after prior endocrine and chemotherapy treatments.
AstraZeneca Pharma India Limited
New Ventures
AstraZeneca Pharma India Limited has announced it will launch Datopotamab Deruxtecan, marketed as Datverzo, in India in November 2026. Datverzo is approved to treat adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer who have undergone prior endocrine and chemotherapy treatments.
Datverzo has received regulatory import and market permission from the Drugs Controller General of India as communicated earlier in December 2025.
The drug is specifically indicated for adults with unresectable or metastatic hormone receptor (HR)–positive, human epidermal growth factor receptor 2 (HER2)–negative breast cancer, including those with IHC 0, IHC 1+ or IHC 2+/ISH- status, who have previously received endocrine-based therapy and chemotherapy for metastatic disease.
The launch signifies AstraZeneca Pharma India Limited's expansion in oncology therapeutics by providing a treatment option for patients with metastatic breast cancer in India.
Highlights
- Datverzo launch scheduled for November 2026 in India by AstraZeneca Pharma India Limited.
- Drug approved for adults with unresectable/metastatic HR-positive, HER2-negative breast cancer.
- Prior treatment with endocrine and chemotherapy required for indication.
- Regulatory import and market permission granted by the Drugs Controller General of India in December 2025.
Key Data Snapshot
What happened
- AstraZeneca Pharma India Limited will launch Datverzo in India in November 2026.
- Datverzo is approved for the treatment of adult patients with unresectable or metastatic hormone receptor-positive, HER2-negative breast cancer.
- The drug is indicated for patients who have received prior endocrine-based therapy and chemotherapy for metastatic disease.
Regulatory and governance context
- Import and Market Permission for Datverzo granted by the Drugs Controller General of India, communicated in December 2025.
- The company has informed stock exchanges of the upcoming launch and regulatory status as part of compliance updates.
Highlights
- Datverzo launch scheduled for November 2026 in India by AstraZeneca Pharma India Limited.
- Drug approved for adults with unresectable/metastatic HR-positive, HER2-negative breast cancer.
- Prior treatment with endocrine and chemotherapy required for indication.
- Regulatory import and market permission granted by the Drugs Controller General of India in December 2025.
Disclosures
- Drugs Controller General of India Form CT-20
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