In a significant advancement for oncology therapeutics, the U.S. Food and Drug Administration has granted expanded approval to the targeted cancer drug Enhertu for first-line treatment of HER2-positive metastatic breast cancer. The Monday authorization permits its use in combination with Roche’s Perjeta (pertuzumab) for adult patients with advanced HER2-positive breast cancer confirmed through FDA-approved diagnostic testing.
Developed through collaboration between Daiichi Sankyo and AstraZeneca, Enhertu (famously known as trastuzumab deruxtecan) initially received FDA endorsement in December 2019 as a third-line intervention for HER2-positive breast cancer patients. This latest regulatory milestone represents a substantial therapeutic elevation, moving the drug combination to the forefront of treatment protocols for this aggressive cancer subtype.
The expanded indication addresses a critical unmet need in oncology by providing clinicians with a powerful first-line therapeutic option for patients presenting with advanced HER2-positive disease. This approval follows comprehensive clinical data demonstrating the combination’s efficacy in targeting HER2-positive cancer cells through complementary mechanisms of action.
Medical experts anticipate this regulatory decision will reshape treatment paradigms for newly diagnosed advanced HER2-positive breast cancer patients, potentially establishing the Enhertu-Perjeta combination as a new standard of care in frontline metastatic settings.