Approval Confirmed for ENHERTU in HER2-Low Breast Cancer

ENHERTU Receives Priority Review for HER2-Low Metastatic Breast Cancer

AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application (sBLA) for ENHERTU (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the US. This pertains to the treatment of adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) or ultralow (IHC 0 with membrane staining) breast cancer who have already undergone at least one endocrine therapy in the metastatic context. These steps are based on positive results from the DESTINY-Breast06 Phase III trial that compared ENHERTU to traditional chemotherapy treatments.

What is Priority Review?

The Priority Review designation from the FDA helps expedite the assessment process for medicines that promise significant improvement over existing therapies, especially those that can enhance patient outcomes or compliance. The target action date for FDA's decision is expected to be set within the first quarter of 2025.

Breakthrough Therapy Designation and the Need for New Treatments

Recently, ENHERTU also received Breakthrough Therapy Designation (BTD) by the FDA. This classification accelerates the development of drugs intended to address serious health conditions and those with unmet medical needs. Given that HR-positive, HER2-negative breast cancer constitutes around 70% of breast cancer cases, the need for effective therapies remains high. Although these tumors are classified as HER2-negative, many still express low levels of HER2.

Understanding HER2 Expression in Breast Cancer

Research suggests that up to 85-90% of tumors previously labeled as HR-positive, HER2-negative may actually fall into the HER2-low or ultralow categories. This means they might benefit from HER2-targeted treatments like ENHERTU, which has the potential to change the landscape for these patients after they have received endocrine therapies.

Significant Trial Results and Clinical Implications

Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the limited aid endocrine therapies offer after extended treatment for HR-positive metastatic breast cancer. Many patients do not achieve a favorable response to subsequent chemotherapy, which highlights the critical need for innovative solutions in treating these individuals.

DESTINY-Breast06 showed ENHERTU led to a 37% reduced risk of disease progression or death compared to chemotherapy. The observed median progression-free survival (PFS) was reported as 13.2 months for those receiving ENHERTU, versus 8.1 months for the chemotherapy cohort. This indicates a critical shift in what may become the standard of care.

The Safety Profile of ENHERTU

Throughout the DESTINY-Breast06 trial, ENHERTU maintained a safety profile consistent with previous studies, showing no new significant safety issues. The insights gained from this study can guide ongoing research and clinical applications for HER2-positive and HER2-low breast cancer treatments.

ENHERTU's Global Approval Status

Currently, ENHERTU is approved in over 65 countries for patients with HER2-low metastatic breast cancer who have undergone prior systemic treatments in the metastatic setting. This wide-reaching approval reinforces the growing consensus around the drug's efficacy and its promise to facilitate better outcomes for patients with HER2-low breast cancer.

Future Directions in Breast Cancer Treatment Development

The collaboration between AstraZeneca and Daiichi Sankyo is expanding global efforts to develop ENHERTU across various HER2-targetable cancers. The ongoing evaluation processes seek to continuously reshape the clinical treatment landscape, potentially offering hope to patients facing limited options.

Frequently Asked Questions

What does the approval of ENHERTU mean for patients?

The recent approval indicates a crucial treatment option for patients with HER2-low metastatic breast cancer after endocrine therapies, promising to improve outcomes and enhance survival rates.

What are the benefits of the Breakthrough Therapy Designation?

This designation allows for faster development and regulatory review for crucial therapies aimed at serious conditions, aiming to expedite patient access to potentially life-saving medications.

How does ENHERTU differ from traditional chemotherapy?

ENHERTU is targeted primarily at HER2-expressing cells, potentially leading to better patient outcomes and fewer side effects compared to traditional chemotherapeutic agents which can affect both healthy and cancerous cells.

What populations are more likely to benefit from ENHERTU?

Patients with metastatic HR-positive, HER2-low, or ultralow breast cancer who have undergone prior endocrine therapy are the primary populations targeted by ENHERTU.

What does ongoing research involve regarding ENHERTU?

AstraZeneca and Daiichi Sankyo are focused on researching and expanding the use of ENHERTU across a broader patient population and various HER2-targetable cancers through comprehensive clinical trials.

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