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 ineligible for endocrine therapy.
“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, executive vice president, oncology R&D, AstraZeneca, in a statement. “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.”
At the beginning of the year, AstraZeneca and Daiichi Sankyo announced that the FDA accepted the supplemental Biologics License Application (sBLA) for Enhertu.
AZN shares were mostly flat, ticking up 0.17% to 10,350 pence, while Daiichi Sankyo shares were up 4%, hitting $23.72.
Filed Under: Oncology