Datopotamab Deruxtecan New BLA Submitted for Accelerated Approval in the U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer
DAIICHI SANKYO S/ADR (DSNKY)
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Source: Business Wire
Daiichi Sankyo and AstraZeneca’s new application is based on the TROPION-Lung05 phase 2 trial and supported by data from additional trials including TROPION-Lung01Previously submitted BLA based on TROPION-Lung01 phase 3 trial for patients with nonsquamous NSCLC has been voluntarily withdrawn TOKYO & BASKING RIDGE, N.J.--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have submitted a new Biologics License Application (BLA) for accelerated approval in the U.S. for datopotamab deruxtecan (Dato-DXd) for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.The companies have voluntarily withdrawn the BLA in the U.S. for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 phase 3 trial.The decision to submit a new
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