The US Food and Drug Administration (FDA) has granted AstraZeneca (AZ; NASDAQ: AZN) and Daiichi Sankyo (TYO: 4568) two breakthrough therapy designations (BTDs) for their co-developed antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan). This recognition is for its potential as a therapy for HER2-positive malignancies, including unresectable or metastatic solid tumors that have progressed after prior treatments and have no therapeutic alternatives, as well as for metastatic colorectal cancer (mCRC) after two or more regimens.
HER2-Positive Cancer Prevalence and Clinical Need
According to the press release, the prevalence of HER2-positive status in metastatic tumors ranges from 1% to 28%, and in colorectal cancer (CRC) cases, it is up to 5%. These BTDs are based on preliminary Phase II data, which indicate the potential efficacy of Enhertu in addressing this significant unmet clinical need.
Accelerated Development and Review Process
The breakthrough therapy designations will expedite the development and review process for Enhertu, potentially bringing this treatment to patients with HER2-positive cancers more quickly. This acceleration is crucial for patients with limited treatment options and highlights the FDA’s commitment to making promising new therapies available as swiftly as possible.-Fineline Info & Tech
