The HER2-directed antibody-drug conjugate Enertu (trastuzumab deruxtecan) has won its fifth breakthrough therapy designation from the FDA.
Enhertu was developed jointly by AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS: DSNKY).
The latest designation relates to treating adults with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer.
Of the five breakthrough therapy designations for the drug, three are for breast cancer, while the other two are in lung and gastric cancers, respectively.
In particular, the designation covers adults who have received prior systemic therapy for metastatic breast cancer or who have experienced disease recurrence within six months of finishing adjuvant chemotherapy.
In addition, the designation specifies that patients with hormone receptor (HR) positive breast cancer have received or be inelig…