AstraZeneca(AZN,AZN.L,ZEG.DE,AZN.ST) and Daiichi Sankyo Company's (4568.T) ENHERTU has been approved by the US Food and Drug Administration (FDA) for both neoadjuvant or use before surgery and adjuvant or use following surgery treatment of patients with HER2-positive early breast cancer, based on results from the DESTINY-Breast11 and DESTINY-Breast05 Phase III trials.
ENHERTU is a specifically engineered HER2-directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and is being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
FDA Approval
Notably, in the neoadjuvant setting, ENHERTU, followed by a taxane, trastuzumab, and pertuzumab (THP), has been approved for the treatment of adult patients with HER2-positive Stage II or Stage III breast cancer.
In the adjuvant setting, ENHERTU has been approved for the treatment of adult patients with HER2-positive breast cancer who have residual invasive disease following trastuzumab (with or without pertuzumab) and taxane-based treatment.
In DESTINY-Breast11, ENHERTU followed by THP as neoadjuvant treatment achieved a pathologic complete response (pCR) rate of 67.3%, compared with 56.3% for dose-dense doxorubicin and cyclophosphamide followed by THP [ddAC-THP].
Favourable Drivers
Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide, as noted by the firm.
ENHERTU is already approved in more than 95 countries, including the US, as a treatment for patients with HER2-positive metastatic breast cancer.
Following these approvals in the US, $155 million in milestone payments is due from AstraZeneca to Daiichi Sankyo for both indications.
"These approvals mark an important step forward, expanding the possibility of a cure to more patients for the first time in many years and positioning ENHERTU as a foundational treatment in early breast cancer," said Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca.
4568.T has traded between 2,443 Japanese Yen and 4,178 Japanese Yen over the last year. Currently 4568.T is up 1.81% at 2,620.50 Japanese Yen.
AZN has traded between $137.22 and $212.71 over the last year. The stock closed Friday's trade at $181.58, down 1.83%.In the premarket, AZN is up 0.22% at $182.08.
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