SEC recommends approval to Enhertu for two additional indications in India

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21 July 2026: SEC recommends approval to Enhertu for two additional indications in India

India’s Subject Expert Committee has recommended approval of two additional indications for AstraZeneca and Daiichi Sankyo’s HER2-directed antibody-drug conjugate Enhertu for patients with HER2-positive early-stage breast cancer, aligning with the recent US FDA approvals
The recommendations are supported by the global phase 3 DESTINY-Breast11 and DESTINY-Breast05 trials. DESTINY-Breast11 supported the neoadjuvant indication, while DESTINY-Breast05 supported the adjuvant indication for patients with residual invasive disease after neoadjuvant therapy. The SEC also granted a local phase 3 trial waiver for the adjuvant indication, subject to AstraZeneca conducting a phase 4 study in India following approval
The expanded indications address an important unmet need by bringing Enhertu into earlier stages of HER2-positive breast cancer, with the potential to improve outcomes for high-risk patients before surgery and for those with residual disease following neoadjuvant treatment
Enhertu is a HER2-targeted antibody-drug conjugate that combines trastuzumab with a cleavable linker and a potent topoisomerase I inhibitor (DXd) payload, enabling selective delivery of chemotherapy to HER2-expressing tumor cells while providing a bystander antitumor effect
Strategically, the SEC’s recommendation represents another significant step toward expanding Enhertu’s use in India beyond metastatic disease, reinforcing AstraZeneca and Daiichi Sankyo’s strategy of moving the HER2 ADC into earlier treatment settings and strengthening its position as a standard-of-care therapy across multiple stages of HER2-positive breast cancer