A new Biologics License Application (BLA) for US accelerated approval has been submitted for datopotamab deruxtecan as a treatment for adults with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy, according to an announcement from Daiichi Sankyo and AstraZeneca.
The companies have “voluntarily withdrawn the BLA in the U.S. for datopotamab deruxtecan for patients with advanced or metastatic nonsquamous NSCLC based on the TROPION-Lung01 phase 3 trial,” according to the announcement. “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 Drug Administration.”
The new BLA is based on results from the phase 2 TROPION-Lung05 trial and is “supported by data from the TROPION-Lung01 phase 3 and TROPION-PanTumor01 phase 1 trials,” officials said. New results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC in the TROPION-Lung05 and TROPION-Lung01 trials will be featured in a late-breaking presentation at the upcoming European Society for Medical Oncology Asia 2024 Congress.
Daiichi Sankyo and AstraZeneca are evaluating datopotamab deruxtecan alone and with osimertinib as a treatment for patients with advanced or metastatic EGFR-mutated nonsquamous NSCLC in the ongoing phase 3 TROPION-Lung14 and TROPION-Lung15 trials.
Company officials also highlighted the ongoing phase 3 AVANZAR and TROPION-Lung10 trials in first-line advanced or metastatic nonsquamous NSCLC, noting that they “have the potential to validate the QCS (quantitative continuous scoring) biomarker for TROP2 identified in an exploratory analysis of TROPION-Lung01.”
An additional trial in patients with biomarker-positive tumors in the second-line nonsquamous NSCLC setting is planned, according to the announcement.
Source: Business Wire
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