Enhertu granted FDA Breakthrough Therapy Designation

pharmafile | April 27, 2022 | News story | Research and Development  

AstraZeneca’s Enhertu® (fam-trastuzumab deruxtecan-nxki) has been granted breakthrough therapy designation in the US for adult patients with HER2-low metastatic breast cancer. The designation means that Enhertu has been granted five Breakthrough Therapy Designations, including three in breast cancer, and one in both lung and gastric cancers.

The company announced that in its DESTINY-Breast04 trial, Enhertu demonstrated a significant improvement in both progression-free survival and overall survival.

The latest designation has been granted for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting, or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Additionally, patients with hormone receptor (HR) positive breast cancer should also have received, or be ineligible for, endocrine therapy. Endocrine therapy is a hormone therapy, which is the use of hormones in medical treatment. Within breast cancer, hormone therapy is a treatment that stops the effect of oestrogen on breast cancer cells.

FDA Breakthrough Therapy Designations are designed to accelerate the development and regulatory review of potential new medicines, intended to treat a serious condition, and address significant unmet medical need.

“Today’s news is a significant validation of the potential we see for the historic DESTINY-Breast04 trial to enable a paradigm shift in how breast cancer is classified by targeting the full spectrum of HER2 expression,” said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&D, AstraZeneca. “ENHERTU continues to show transformative potential, and this milestone represents an important advance for patients with HER2 low metastatic breast cancer who are in urgent need of new treatment options and better outcomes.”

Breast cancer is the most common form of cancer, and is one of the leading causes of cancer-related deaths worldwide in the US. More than 290,000 new cases of the disease are expected to be diagnosed in 2022.

Ana Ovey

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