India Pharma Outlook Team | Tuesday, 16 December 2025
AstraZeneca and Daiichi Sankyo received FDA approval for Enhertu as a first-line therapy for HER2-positive metastatic breast cancer, altering treatment for newly diagnosed patients.
The ruling will allow the use of Enhertu with Perjeta developed by Roche at an early stage of the disease rather than as a last resort.
The approval is based on the results of the DESTINY -Breast09 trial, which discovered that Enhertu and Perjeta combined is better than the current standard of care.
The median progression-free survival of patients under the new regimen was approximately 40.7 months compared with 26.9 months under the trastuzumab, pertuzumab, and chemotherapy. The information also showed the reduced pace of the diseases and increased rates of the tumor response.
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On an industry basis, the approval enhances the positions of AstraZeneca and Daiichi Sankyo in the market of HER2-positive breast cancer treatment. Although Enhertu has been extensively utilized once the disease has progressed, this broadened label significantly enhances its utilization earlier in the treatment. It also stimulates further investment in antibody drug conjugates that are now taking center stage on oncology pipelines.
Enhertu refers to an antibody-drug conjugate that has the ability to deliver the chemotherapy directly to cells expressing the HER2 protein within cancer cells. Together with Perjeta that prevents HER2 signaling, it provides a more targeted choice to patients with metastatic disease.
The entire survival results of the research are yet to be known, but medical professionals will soon embrace the regimen due to its obvious advantage of holding the disease at bay.
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