AstraZeneca Pharma India Ltd. has received permission from the Central Drugs Standard Control Organisation to import, sell and distribute Trastuzumab Deruxtecan for an additional breast cancer indication in India. According to the company's exchange filing, the approval covers Trastuzumab Deruxtecan 100 mg/5 mL lyophilised powder for concentrate for solution for infusion, sold under the brand name Enhertu. The permission from the Central Drugs Standard Control Organisation, under the Directorate General of Health Services, Government of India, paves the way for marketing Enhertu in India for the additional indication, opening up a significant new market segment for the targeted treatment. This regulatory clearance enables AstraZeneca to move toward marketing Enhertu in India for this newly approved indication, subject to further statutory approvals, potentially expanding its oncology portfolio and access to advanced breast cancer treatments.
Enhertu is a prescription cancer medicine used to treat certain types of breast, lung and stomach cancers that have the HER2 protein. As reported by the company, Enhertu is now indicated for the adjuvant treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following neoadjuvant trastuzumab, with or without pertuzumab, and taxane-based treatment. The targeted treatment finds HER2-positive cancer cells and delivers chemotherapy directly to them, addressing a critical need in the treatment of early-stage breast cancer with specific characteristics. This expanded approval aims to provide wider patient access to the therapy for those with HER2-positive breast cancer who have residual invasive disease after prior treatments.
The approval applies to patients whose tumours are HER2-positive, classified as IHC 3+ or ISH+. According to the company's statement, this covers patients with HER2-positive breast cancer with residual invasive disease after undergoing neoadjuvant treatment that included Trastuzumab (with or without Pertuzumab) and taxane-based therapies. The launch will be subject to receipt of any other applicable statutory approvals, as noted by AstraZeneca Pharma India. This newly approved indication specifies that Enhertu is now indicated for the adjuvant treatment of adult patients diagnosed with HER2-positive (IHC 3+ or ISH+) breast cancer who exhibit residual invasive disease after specific prior treatments.
The receipt of this permission represents a significant step forward for AstraZeneca Pharma India's oncology portfolio, enabling the marketing of Enhertu in India for this specific additional indication. As reported by the company, this paves the way for wider patient access to the therapy, subject to any further related statutory approvals that may be required. The move underscores the company's focus on specialized oncology segments and may enhance its competitive positioning in the Indian market for targeted cancer therapies. AstraZeneca Pharma India Limited operates in the pharmaceutical and healthcare industry, focusing on the import, marketing, and distribution of innovative prescription medicines in India, with its market presence centered on high-value, specialty treatments often introduced through regulatory approvals for advanced indications. The company recently reported a 22.95% year-on-year decline in standalone net profit to ₹44.88 crore for Q4 FY26, compared with ₹58.25 crore in the corresponding quarter of the previous fiscal, while revenue from operations rose 20.42% year-on-year to ₹578.61 crore during the quarter.
