Daiichi Sankyo Co., Ltd (4568.T) and AstraZeneca Plc (AZN) announced that the U.S. FDA has granted Breakthrough Therapy Designation to ENHERTU as post-neoadjuvant therapy for adult patients with HER2-positive early breast cancer with residual invasive disease following neoadjuvant treatment and at high risk of recurrence.
Breast Cancer is the second most common cancer worldwide, with more than two million cases diagnosed annually. Despite advanced in neoadjuvant therapy, nearly half of patients fail to achieve pathologic complete response, leaving them vulnerable to recurrence and progression to metastatic disease.
ENHERTU (trastuzumab deruxtecan), a HER2-directed antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and jointly developed with AstraZeneca, has already been approved for multiple indications across breast, gastric, lung, and colorectal cancers. It is currently available in more than 90 countries for HER2-positive metastatic breast cancer, HER2-low breast cancer, HER2-positive gastric cancer, among other solid tumors.
The FDA's latest designation was supported by results from the Phase 3 DESTINY- Breast05 trial, which demonstrated that ENHERTU significantly improved invasive disease-free survival compared to trastuzumab emtansine (T-DM1) in patients with HER2-positive early breast cancer who had residual disease after neoadjuvant therapy.The study was presented at the 2025 European Society of Medical Oncology Congress and published in The New England Journal of Medicine.
Safety data from ENHERTU's clinical program remain consistent with its known profile, with interstitial lung disease/pneumonitis and neutropenia among the most notable adverse events.
"This tenth Breakthrough Therapy Designation reinforces how ENHERTU continues to deliver transformational results that advance the treatment of breast cancer," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "DESTINY-Breast05 clearly demonstrated that ENHERTU may help halt invasive disease recurrence over the current standard of care."
Susan Galbraith, Executive Vice President of Oncology R&D atAstraZeneca, added: "This designation highlights ENHERTU's impressive clinical benefit in the post-neoadjuvant setting and reinforces its role as a critical treatment option for patients at high risk of recurrence."
In parallel, Daiichi Sankyo announced initiation of the DENSITY- Endometrial02 Phase 3 trial, evaluating ENHERTU as adjuvant therapy in patients with HER2-expressing endometrial cancer.
The study, conducted in collaboration with the GOG Foundation and ENGOT, will enroll approximately 710 patients globally to compare ENHERTU with standard chemotherapy regimens, with or without radiotherapy. This marks the first trial to investigate a HER2-directed therapy in the adjuvant setting for endometrial cancer, a disease with high recurrence risk and limited targeted treatment options.
ENHERTU has now received 10 Breakthrough Therapy Designations, including six for breast cancer and four for other HER2-positive or HER2- mutant solid tumors, making it one of the most widely recognized ADCs in oncology.
The drug generated annual global sales of approximately $3,754 million in fiscal year 2024 and $3,575 million in the first nine months of 2025.
Daiichi Sankyo Co., Ltd. shares fell to 0.45%, to close at ¥3285 on Friday.
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