AstraZeneca Rises on Expanded FDA Approval for Cancer Drug Enhertu
The drug, developed with Daiichi Sankyo, is now approved as a first-line treatment for a form of metastatic breast cancer, opening a significant new market.
Shares of AstraZeneca PLC (NASDAQ: AZN) climbed Tuesday after the U.S. Food and Drug Administration (FDA) approved an expanded use for its blockbuster cancer therapy, Enhertu, positioning the drug as a first-line treatment for a specific group of breast cancer patients.
The stock rose approximately 1.9% to $91.56 in morning trading as investors reacted to the news, which significantly widens the commercial opportunity for one of the pharmaceutical giant's key growth drivers. The approval, granted to AstraZeneca and its development partner Daiichi Sankyo, is for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer.
This regulatory milestone is particularly significant as it moves Enhertu into a first-line setting for this patient population. According to the company's announcement, this is the first new treatment option in a decade for newly diagnosed patients with HER2-positive metastatic breast cancer.
The FDA's decision was based on compelling results from the Phase III DESTINY-Breast09 clinical trial. The study demonstrated that Enhertu, when used in combination with pertuzumab, reduced the risk of disease progression or death by a notable 44% compared to the current standard of care. Patients in the trial receiving the Enhertu combination had a median progression-free survival of 40.7 months, a substantial improvement over the 26.9 months for the standard therapy group.
Enhertu, a precisely engineered antibody-drug conjugate (ADC), has been a cornerstone of AstraZeneca’s oncology portfolio since its initial approval. It was first cleared in 2019 for patients who had already undergone multiple prior treatments. Subsequent approvals have steadily moved it into earlier stages of therapy, but this latest decision for first-line use is the most commercially significant expansion yet.
Under the terms of the collaboration, AstraZeneca will make a a $150 million milestone payment to Daiichi Sankyo. The partnership, which began in 2019, has been instrumental in establishing Enhertu as a leading treatment across multiple cancer types.
The approval solidifies AstraZeneca’s competitive position in the lucrative oncology market, particularly in breast cancer, which remains a key focus for the Anglo-Swedish drugmaker. While the safety profile was consistent with previous studies, the label notes the risk of interstitial lung disease, a known side effect that requires careful patient monitoring. The expanded U.S. nod is expected to be a major contributor to the company's revenue growth as it continues to build out its deep pipeline of cancer therapies.