AstraZeneca Pharma India Gets CDSCO Approval to Import Cancer Drug Datverzo

AstraZeneca Pharma India Limited has received regulatory approval from the Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Government of India, to import and distribute a new cancer treatment drug in the Indian market.

Regulatory Approval Confirmed

The company has obtained official permission to import for sale and distribution of Datopotamab Deruxtecan powder for concentrate for solution for infusion 100mg (r-DNA origin), which will be marketed under the brand name Datverzo. This approval represents a significant milestone as it introduces a new therapeutic option to the Indian pharmaceutical market.

Parameter:	Details
Drug Name:	Datopotamab Deruxtecan powder for concentrate
Strength:	100mg (r-DNA origin)
Brand Name:	Datverzo
Regulatory Authority:	Central Drugs Standard Control Organization (CDSCO)
Approval Status:	Confirmed for import and distribution

Treatment Indication and Patient Criteria

Datopotamab Deruxtecan is specifically indicated for treating adult patients with a particular type of breast cancer. The drug targets patients with unresectable or metastatic, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

The treatment is designated for patients who meet specific clinical criteria including breast cancer classification of IHC 0, IHC 1+ or IHC 2+/ISH-, prior treatment history with endocrine-based therapy and chemotherapy, and unresectable or metastatic disease stage.

Patient Criteria:	Specification
Cancer Type:	HR-positive, HER2-negative breast cancer
Disease Stage:	Unresectable or metastatic
Prior Treatment:	Endocrine-based therapy and chemotherapy
Classification:	IHC 0, IHC 1+ or IHC 2+/ISH-

Market Authorization and Implementation

The CDSCO approval paves the way for AstraZeneca Pharma India to market Datopotamab Deruxtecan in India for the specified indication. The company has confirmed that marketing activities remain subject to receiving any additional statutory approvals that may be required for full commercial launch.

This regulatory milestone represents AstraZeneca Pharma India's continued commitment to bringing innovative cancer treatments to Indian patients, particularly those with specific breast cancer subtypes who have limited treatment options after standard therapies.

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
+0.31%	+1.79%	+1.45%	+4.44%	+42.73%	+112.23%

AstraZeneca Pharma India Limited has announced a change in its leadership team. Dr. Ajay Sharma, the company's Director of Corporate Affairs, has decided to pursue his career outside the organization.

Key Details of the Resignation

Aspect	Details
Resigning Executive	Dr. Ajay Sharma
Position	Director - Corporate Affairs
Last Working Day	November 26, 2025
Reason for Departure	To pursue career opportunities outside the organization

Company's Response

AstraZeneca Pharma India Limited has acknowledged Dr. Sharma's decision and is actively searching for a suitable replacement for the position. The company has expressed its best wishes for Dr. Sharma's future endeavors.

Transition Period

Dr. Sharma will continue in his role during a handover period, which is set to conclude by the close of business hours on November 26, 2025. This transition period is aimed at ensuring a smooth transfer of responsibilities and maintaining continuity in the company's corporate affairs operations.

Regulatory Compliance

In line with regulatory requirements, AstraZeneca Pharma India Limited has made this announcement pursuant to Regulation 30 of the Securities and Exchange Board of India (SEBI) Listing Obligations and Disclosure Requirements Regulations, 2015. The company has informed both the BSE Limited and the National Stock Exchange of India Limited about this development.