Key Highlights:
- The CDSCO has approved Enhertu (trastuzumab deruxtecan; 100 mg/5 mL) for the neoadjuvant treatment of adults with HER2-positive (IHC 3+ or ISH+) Stage II or III breast cancer, followed by a taxane, trastuzumab, and pertuzumab (THP). The approval expands the use of trastuzumab deruxtecan into the early breast cancer setting, where treatment before surgery can help assess tumour response and guide post-surgical decisions.
- The approval is supported by the P-III DESTINY-Breast11 trial, in which trastuzumab deruxtecan followed by THP demonstrated the highest reported pCR rate in HER2-positive early breast cancer for a registrational neoadjuvant study. The regimen showed improvement in pathological complete response (pCR) versus ddAC-THP, with an absolute difference of 11.2%. The pCR benefit was observed regardless of hormone receptor status or disease stage.
- The approval broadens AstraZeneca’s trastuzumab deruxtecan portfolio in India, where the therapy is already approved for specified settings in metastatic HER2-positive breast cancer, as well as HER2-low and HER2-ultralow metastatic breast cancer, HER2-positive g/gej adenocarcinoma after prior anti-HER2 therapy, and certain unresectable or metastatic HER2-positive solid tumours.
Implications:
The approval broadens AstraZeneca’s trastuzumab deruxtecan franchise in India from later-line metastatic use into the earlier, potentially larger HER2-positive breast cancer pool, reinforcing Enhertu as a premium multi-indication asset and extending its lifecycle across both early and advanced disease settings. Because DESTINY-Breast11 showed the highest reported pCR in a registrational neoadjuvant study and an 11.2-point absolute improvement versus ddAC-THP, the drug may shift standard-of-care discussions at tertiary oncology centres toward a more effective but likely higher-cost regimen, with uptake depending on access, reimbursement, and hospital formulary decisions.
Source: AstraZeneca
