April 5 (Reuters) - The U.S. Food and Drug Administration on Friday gave accelerated approval for the expanded use of Daiichi Sankyo (4568.T), opens new tab and AstraZeneca's (AZN.L), opens new tab drug to treat patients with a type of solid tumor.
Daiichi Sankyo`s Enhertu (fam-trastuzumab deruxtecan-nxki) Receives Suppl Approval in the U.S.
ENHERTU® Approved in the U.S. as First Tumor Agnostic HER2 Directed Therapy for Previously Treated Patients with Metastatic HER2 Positive Solid Tumors
REJOICE-Ovarian01 Phase 2/3 Trial of Raludotatug Deruxtecan Initiated in Patients with Platinum-Resistant Ovarian Cancer
AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The Prescription Drug User Fee Act date, the US Food and Drug Administration (FDA) action date for its regulatory decision, is during the first quarter of 2025.
CHMP positive opinions for bempedoic acid and the bempedoic acid / ezetimibe
Two Datopotamab Deruxtecan Applications Validated in EU for Patients with NSCLC
Datopotamab deruxtecan Biologics License Application accepted in the US for patients with previously treated advanced nonsquamous non-small cell lung cancer
Daiichi invests 1 bln eur near Munich to make precision cancer drugs