AstraZeneca and Daiichi Sankyo Seek FDA Approval for Datopotamab Deruxtecan in EGFR-Mutated NSCLC
核心洞察
AstraZeneca and Daiichi Sankyo have submitted a Biologics License Application (BLA) to the FDA for datopotamab deruxtecan (Dato-DXd).
The BLA targets the treatment of locally advanced or metastatic EGFR (搜索)-mutated non-small cell lung cancer (搜索) (NSCLC) in patients who have previously received systemic therapies.
This submission is based on data from the Phase II TROPION-Lung05 trial, supported by findings from Phase III TROPION-Lung01 and Phase I TROPION-PanTumor01 trials.
AstraZeneca and Daiichi Sankyo have announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for accelerated approval of datopotamab deruxtecan (Dato-DXd) in the treatment of non-small cell lung cancer (搜索) (NSCLC). The application targets patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR (搜索)) NSCLC who have previously undergone systemic therapies. This strategic move follows consultations with the FDA and involves the withdrawal of a previous BLA for the therapy.
Clinical Trial Data Supporting BLA Submission
The BLA submission is supported by outcomes from the Phase II TROPION-Lung05 trial, which involved 137 patients across Europe, Asia, and North America. The submission also incorporates findings from the Phase III TROPION-Lung01 and Phase I TROPION-PanTumor01 trials. TROPION-Lung01 was designed to assess the potential of datopotamab deruxtecan to improve upon standard-of-care chemotherapy in a broad, previously treated, advanced lung cancer patient population.
Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, noted that the results from TROPION-Lung01, combined with data from TROPION-Lung05, demonstrated a particularly pronounced benefit for patients with EGFR (搜索) mutations. This informed discussions with the FDA and the decision to seek accelerated approval of datopotamab deruxtecan in this specific patient population. Galbraith also highlighted the exploratory data from TROPION-Lung01, which supports ongoing biomarker development to be validated in future Phase III lung cancer trials.
Datopotamab Deruxtecan: A Novel Antibody-Drug Conjugate
Datopotamab deruxtecan is a trophoblast antigen 2 (TROP2 (搜索))-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and co-developed with AstraZeneca. The collaboration is also investigating the efficacy of datopotamab deruxtecan as a monotherapy and in combination with Tagrisso (osimertinib) in the ongoing Phase III trials, TROPION-Lung14 and TROPION-Lung15, for treating advanced or metastatic EGFR (搜索)-mutated nonsquamous NSCLC.
Addressing Unmet Needs in EGFR-Mutated NSCLC
Treating EGFR (搜索)-mutated non-small cell lung cancer (搜索) remains a significant challenge, especially following disease progression, due to the complexity and variability of these mutations often leading to resistance. Ken Takeshita, Global Head of R&D at Daiichi Sankyo, emphasized that the potential approval of datopotamab deruxtecan could offer renewed hope for patients with this formidable disease.