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 [Yahoo! Finance]
AstraZeneca PLC - American Depositary Shares (AZN)
Last astrazeneca plc - american depositary shares earnings: 2/5 04:00 pm
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Source: Yahoo! Finance
Previously submitted BLA based on TROPION-Lung01 phase 3 trial for patients with nonsquamous NSCLC has been voluntarily withdrawn TOKYO & BASKING RIDGE, N.J., November 12, 2024 BUSINESS WIRE )--Daiichi Sankyo (TSE: 4568) and AstraZeneca (LSE/STO/Nasdaq: AZN) have submitted a new Biologics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 The companies have voluntarily withdrawn the BLA in the U.S. for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 phase 3 trial.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 BLA for EGFR-mutated NSCLC and withdraw the previously submitted BLA for nonsquamous NSCLC was informed by feedback from the U.S. Food and
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AZN
Sec Filings
- 11/13/24 - Form 6-K
- 11/12/24 - Form 6-K
- 11/12/24 - Form 6-K
- AZN's page on the SEC website