Fourteenth breakthrough therapy designation granted by FDA across the oncology portfolio of Daiichi Sankyo
FDA grants accelerated approval to zongertinib for HER2 TKD-Mutated Non-Squamous NSCLC
Longer-term follow up in the FLAURA2 Phase III trial confirms the favourable benefit-risk profile of this combination
First and only TROP2-directed therapy approved in the US for the treatment of lung cancer
46% reduction in the risk of disease progression or death, and 27% reduction in the risk of death, in an aggressive cancer type with limited survival and few treatment options
Aumolertinib can be used in patients who have tested positive for a mutation in a gene called epidermal growth factor receptor
This is specifically for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition
Approval based on AEGEAN Phase III trial results which showed a 32% reduction in the risk of recurrence, progression or death vs. neoadjuvant chemotherapy alone
Zongertinib would be the first orally administered, targeted therapy for previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer (NSCLC), if approved
Recommendation based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival to more than three years
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