ENHERTU® Secures Dual Breakthrough Therapy Designations from US Regulatory Authorities
ENHERTU® has recently been granted two additional Breakthrough Therapy Designations (BTDs) by regulatory authorities in the United States. These designations pertain to the treatment of specific groups of patients facing challenging medical circumstances
The first BTD is intended for adult patients diagnosed with unresectable or metastatic HER2-positive solid tumors, as determined by immunohistochemistry (IHC) scoring of 3+. These patients have experienced disease progression despite prior treatments and have exhausted other viable treatment options.
The second BTD applies to patients with metastatic colorectal cancer who exhibit HER2 positivity, also defined by an IHC score of 3+. These patients have previously undergone two or more treatment regimens.
ENHERTU represents an innovative HER2-directed antibody-drug conjugate (ADC) developed through the collaboration of Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN). This breakthrough therapy offers a promising approach to address a range of challenging cancer cases. The recent grant of BTDs underscores the potential of ENHERTU in transforming the treatment landscape for these patient groups.
These Breakthrough Therapy Designations are significant milestones in the journey to make ENHERTU accessible to patients facing limited treatment options and unfavorable prognoses.
ENHERTU, known as trastuzumab deruxtecan (or fam-trastuzumab deruxtecan-nxki in the U.S.), is a HER2-directed ADC developed using Daiichi Sankyo's proprietary DXd ADC technology. It serves as the flagship ADC within Daiichi Sankyo's oncology portfolio and represents the most advanced program within AstraZeneca's ADC scientific platform.
ENHERTU (5.4 mg/kg) has received approvals in more than 50 countries for the treatment of unresectable or metastatic HER2-positive breast cancer in patients who have previously received one or more anti-HER2-based regimens. Additionally, it has gained approval in over 40 countries for the treatment of unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer among patients who have undergone prior systemic therapy in the metastatic setting or experienced disease recurrence within six months of completing adjuvant chemotherapy, based on results from the DESTINY-Breast04 trial.
Furthermore, ENHERTU (5.4 mg/kg) has received approval in Israel, Japan, and is under accelerated approval in the United States for treating adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) bearing activating HER2 (ERBB2) mutations. It is also approved (6.4 mg/kg) in more than 30 countries for treating adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.
