ENHERTU® Granted Priority Review in the U.S. for Patients with Metastatic HER2 Positive Solid Tumors
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Business Wire
Application based on results from DESTINY-PanTumor02 trial and supported by additional ENHERTU dataSubmission to be reviewed under FDA Real Time Oncology Review and Project OrbisIf approved, Daiichi Sankyo and AstraZeneca’s ENHERTU will potentially be the first HER2 directed treatment and antibody drug conjugate to receive a tumor agnostic indication TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca's (LSE/STO/Nasdaq: AZN) supplemental Biologics License Application (sBLA) for ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior treatment or who have no satisfactory alternative treatment options.ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZenec
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