Enhertu India approval: AstraZeneca expands label (2026)

What the CDSCO approval means for Enhertu in India

AstraZeneca Pharma India Ltd said it has received approval from India’s national drug regulatory body to import, sell and distribute its smart chemotherapy brand Enhertu for an additional indication. The company disclosed the regulatory clearance in an exchange filing. The approval was granted by the Central Drugs Standard Control Organization (CDSCO), under the Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. AstraZeneca said the approval date was June 10. The development expands the labelled use of Enhertu in India and adds to the options available for oncologists treating advanced cancers linked to HER2 expression.

The newly cleared use case described by the company

In its exchange communication, AstraZeneca said the approval allows Enhertu (trastuzumab deruxtecan 100 mg/5 mL) to be used in combination with pertuzumab. The company described the use as a first-line treatment. The eligible population was described as adults with unresectable or metastatic HER2-positive (IHC3+ or ISH+) breast cancer. This is the setting where patients typically need systemic therapy as disease cannot be removed surgically or has spread beyond the primary site. By adding a first-line option, the label expansion can influence how clinicians sequence treatments for advanced HER2-positive breast cancer.

Additional indication details referenced in reports around the approval

Other reports and statements linked to the same CDSCO clearance described an additional indication in adult patients with unresectable or metastatic HER2-positive (IHC3+) solid tumors. The indication was framed for patients who have received prior systemic treatment and have no satisfactory alternative treatment options. In these descriptions, Enhertu is positioned as an antibody-drug conjugate designed to deliver cytotoxic chemotherapy directly to HER2-expressing cancer cells. The formulation referenced across the disclosures is a 100 mg/5 mL vial, supplied as a lyophilized powder for concentrate for solution for infusion.

Product and formulation: what exactly is approved

Across the company disclosures and media reports, the product name and formulation details were consistent. Trastuzumab deruxtecan is marketed under the brand name Enhertu. The approved pack referenced is a 100 mg/5 mL vial of lyophilized powder intended to be prepared as a concentrate for solution for infusion. The approval allows import for sale and distribution, and in some descriptions, import and marketing in India. AstraZeneca’s communications also refer to Enhertu as a “smart chemo-therapy” brand, reflecting its antibody-drug conjugate mechanism.

Context: Enhertu’s India approvals since 2024

AstraZeneca’s India arm has previously indicated that the therapy was approved in 2024 for gastric cancer and HER2-low metastatic breast cancer. Separate reporting also described that, after the latest CDSCO nod, the antibody-drug conjugate launched in 2024 is now approved in India for three indications, including two subtypes of breast cancer. Those subtypes were described as HER2-low and ultralow breast cancer for patients who have received at least one endocrine therapy in a metastatic setting. The latest clearance was described as an additional indication that extends use beyond earlier approvals.

Clinical evidence cited in coverage of the label expansion

In one account of the approval, the additional solid tumor indication was linked to results from a multi-centre global clinical study. The study outcome cited was a median progression-free survival of 11.9 months among patients with solid tumor. The same report also referenced progression-free survival figures of 6.7 months for lung cancer and 5.8 months in a colorectal cancer patient group, in the context of other indications. AstraZeneca Pharma India’s medical leadership also linked the approval to Phase 3 evidence in another statement.

What the company’s leadership said

AstraZeneca Pharma India framed the approval as an expansion of access for patients facing difficult-to-treat cancers. Praveen Rao Akkinepally, Country President and MD, AstraZeneca Pharma India Limited, was quoted as saying: “By bringing Trastuzumab Deruxtecan to patients in India with HER2-positive solid tumors, we take a significant step forward in addressing unmet medical needs and transforming cancer care.”

Another statement attributed to Dr Sandeep Arora, Director Medical Affairs, AstraZeneca Pharma India Limited, said: “This approval is based on results of Phase-3 trial and paves way for new approach to diagnose and treat metastatic breast cancer patients in India with Trastuzumab deruxtecan.”

Commercial backdrop: why Enhertu is a key oncology asset

Enhertu is described as a key oncology asset for AstraZeneca and is marketed with Japan’s Daiichi Sankyo under the trade name Enhertu. The brand’s global sales scale has also been highlighted in coverage. AstraZeneca’s annual financial results were cited as showing that the brand clocked over $1.9 billion in 2024. While sales do not directly translate to India volumes, the figure underlines the importance of the medicine within AstraZeneca’s oncology portfolio.

Summary table of the India regulatory update

Market impact: what changes for clinicians and patients

The immediate impact of the CDSCO nod is that AstraZeneca can import, sell and distribute Enhertu in India for the additional approved use. For oncologists, an expanded label can broaden the set of patients who can be considered for the medicine within approved indications. For patients with unresectable or metastatic disease, the approval is relevant because these settings often involve long treatment pathways and multiple lines of therapy. The company and reports also describe the approval as addressing unmet medical need, particularly for patients who have limited alternatives after prior systemic treatment.

Analysis: why this approval matters in India’s oncology landscape

The approval is notable because it expands access to an antibody-drug conjugate platform in India, with a specified HER2-targeted mechanism. It also signals continued regulatory additions for Enhertu since its India launch in 2024, according to the reports referenced. The presence of both breast cancer and broader solid tumor language in coverage shows how HER2 testing categories such as IHC3+, ISH+, HER2-low, and ultralow are increasingly tied to treatment selection. For investors tracking AstraZeneca Pharma India, the update is principally a regulatory and portfolio milestone, and the company has positioned it as part of its effort to make newer therapies available in the country.

Conclusion

AstraZeneca Pharma India said the CDSCO has cleared Enhertu for an additional indication, enabling import and sale of the 100 mg/5 mL formulation for expanded use in advanced HER2-linked cancers. The company’s June 10 disclosure highlights first-line use in combination with pertuzumab for unresectable or metastatic HER2-positive breast cancer, while other coverage also references an additional HER2-positive solid tumor indication in previously treated patients. The next steps, as noted in one disclosure, include meeting any additional statutory approvals required for marketing the newly approved indication.