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Daiichi Sankyo Co Ltd on Wednesday said its breast cancer therapy, developed alongside Cambridge, England-based pharmaceuticals firm AstraZeneca PLC, has been accepted for review in the US. The Tokyo-based pharmaceutical company said the US Food & Drug Administration has accepted its supplemental biological license application for Enhertu followed by paclitaxel, trastuzumab and pertuzumab, or THP, for the neoadjuvant treatment of adult patients with HER2 positive stage 2 or stage 3 breast cancer. The acceptance was based on results from the Destiny-Breast11 phase 3 trial, which showed that Enhertu followed by THP demonstrated a statistically and clinically meaningful improvement in pathologic compete response rate, along with an improved safety profile. This was compared to dose-dense doxorubicin and cyclophosphamide followed by THP, when used prior to surgery. The FDA’s target action date for their regulatory decision is May 18, 2026. ‘Achieving a pathologic complete response prior to surgery in HER2 positive early-stage breast cancer is critical to reducing the risk of disease recurrence and improving the potential for cure,’ said Ken Takeshita, global head of research and development at Daiichi Sankyo. ‘If approved, Enhertu could change how patients with high risk HER2 positive early-stage breast cancer are treated and we look forward to working closely with the FDA to bring this innovative treatment regimen to patients in this setting.’ Around one in three patients with early-stage breast cancer are considered high-risk, Daiichi Sankyo said, meaning they are more likely to experience disease recurrence and have a poor prognosis. Currently, nearly half of patients who receive neoadjuvant treatment do not achieve pathologic compete response, the company added, ‘reinforcing the unmet medical need for new treatment options’. Shares in Daiichi Sankyo closed up 2.0% at JP¥3,380.00 in Tokyo on Wednesday. AstraZeneca shares jumped 11% to 12,407.00 in London. Copyright 2025 Alliance News Ltd. All Rights Reserved.
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