Regulatory Filing Details
- Addressed to: BSE Limited and National Stock Exchange of India Limited
- Digital signature timestamp: November 07, 2026 at 12:03:31 +05:30
Product Launch Disclosure
AstraZeneca Pharma India Limited will launch Datverzo (brand name for Datopotamab Deruxtecan) in India in November 2026.
Regulatory Approval Background
The company had previously communicated on December 17, 2025 regarding the receipt of Import and Market Permission in Form CT-20 from the Drugs Controller General of India for Datopotamab Deruxtecan.
Therapeutic Indication
Datverzo is approved for the treatment of adult patients with:
- Unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer
- Specific diagnostic criteria: IHC 0, IHC 1+ or IHC 2+/ISH-
- Patient population: Those who have received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease in adults with HR+/HER2– metastatic breast cancer (mBC)
Compliance Purpose
This filing serves as a formal intimation to the stock exchanges regarding the commercial launch of the pharmaceutical product, requesting the exchanges to take this information on record.
No material disclosures under the following sections:
- KMP / Board / Auditor Changes
- Dividend Declaration / Revision / Non-Declaration
- Board Meeting Outcomes
- Financial Results (Standalone & Consolidated)
- Auditor's Report
- Disinvestment / Strategic Actions
- Media Release / Investor Communication