AstraZeneca, Daiichi Sankyo Enhertu gets EMA review for breast cancer subtype
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The European Medicines Agency (EMA) validated an application for AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Enhertu to treat certain patients with breast cancer.
The EMA validated the Type II Variation application for trastuzumab deruxtecan (Enhertu) as a standalone therapy to treat adult patients with unresectable or metastatic HER2 low (immunohistochemistry IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior systemic therapy as their disease spread to other parts or whose cancer returned during or within six months of completing adjuvant chemotherapy.
Patients with hormone receptor (HR) positive breast cancer must additionally have received or be ineligible for endocrine therapy, the companies said in a June 22 press release.
Daiichi said the validation confirmed that the application is complete and begins the scientific review process by the EMA's Committee for Medicinal Products for Human Use (CHMP).
The company noted that the application was based on data from a phase 3 trial, DESTINY-Breast04.
"In addition to the ongoing review of two other applications for the treatment of patients with HER2 positive metastatic breast cancer or gastric cancer in Europe, we are pleased to have received this third validation for HER2 low metastatic breast cancer with the goal of bringing trastuzumab deruxtecan to as many eligible patients with HER2 targetable cancers as possible," said Gilles Gallant, senior vice president, global head, oncology clinical development, Oncology R&D, Daiichi Sankyo.