LONDON (dpa-AFX) - AstraZeneca and Daiichi Sankyo's supplemental Biologics License Application for Enhertu in combination with pertuzumab has been accepted and granted Priority Review in the US for the first-line treatment of adult patients with unresectable or metastatic HER2-positive breast cancer. The sBLA is based on data from the DESTINY-Breast09 Phase III trial. The FDA action date for their regulatory decision, is anticipated during the first quarter of 2026.
The sBLA is being reviewed under the Real-Time Oncology Review programme. RTOR allows the FDA to review components of an application before submission of the complete application.
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