Pharma Focus Asia
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ENHERTU® Breakthrough Therapy Discovered for Low Metastatic Breast Cancer

Daiichi Sankyo and AstraZeneca’s jointly discovered ENHERTU® (fam-trastuzumab deruxtecan-nxki) breakthrough therapy for the treatment of patients with HER2 low metastatic breast cancer. ENHERTU is an engineered HER2 directed antibody drug conjugate (ADC).

ENHERTU® has been developed for adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-negative) breast cancer. It is applicable for patients in metastatic setting who have received prior systemic therapy and also for patients with disease recurrence during or within six months of completing adjuvant chemotherapy.

ENHERTU has shown significant improvements in both progression-free survival (PFS) and overall survival (OS) in patients with HER2 low unresectable and/or metastatic breast cancer with HR positive or HR negative disease when compared with chemotherapy which is the first choice of physicians.

Based on the DESTINY-Breast01 trial, the ENHERTU (5.4 mg/kg) is approved in more than 40 countries for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who has received two or more prior anti-HER2 based regimens. In addition, ENHERTU (6.4 mg/kg) is approved in several countries for the treatment of adult patients with locally advanced or metastatic HER2 positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

ENHERTU represents an important milestone in advancing patients with HER2 low metastatic breast cancer who are in urgent need of new treatment options and better outcomes.

Breast cancer being the most common cancer leads to large number of cancer-related deaths worldwide and in the U.S.

ENHERTU® has been granted Breakthrough Therapy Designation in U.S. for Patients with HER2 Low Metastatic Breast Cancer.

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