(RTTNews) - AstraZeneca Plc. (AZN.L, AZN) and Daiichi Sankyo Company Limited (DSKYF.PK) said that HER2-directed antibody drug conjugate Enhertu has also been granted priority review in the US for the treatment of patients with HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma.
Enhertu (trastuzumab deruxtecan; fam-trastuzumab deruxtecan-nxki in the US) is a HER2-directed antibody drug conjugate or ADC and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca's ADC scientific platform.
Enhertu's supplemental Biologics License Application, accepted by the Food and Drug Administration, was based on results from the DESTINY-Gastric01 randomised Phase II trial. The trial demonstrated a statistically significant and clinically meaningful improvement in objective response rate, the primary endpoint, and overall survival, a key secondary endpoint, for patients treated with Enhertu versus chemotherapy.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, will be during the first quarter of 2021.
Enhertu received Breakthrough Therapy Designation from the FDA in May 2020 for patients with unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received two or more prior regimens including trastuzumab and Orphan Drug Designation for patients with gastric cancer, including GEJ adenocarcinoma. Enhertu has not been approved in the US for gastric or GEJ adenocarcinoma.
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