This approval helps address an urgent unmet need, with about half of people living with early-stage NSCLC experiencing disease recurrence following surgery, despite adjuvant chemotherapy
Decision marks the first approval in Europe for an anti-PD-1/L1 therapy in resectable NSCLC based on positive overall survival results
Combination shows consistent benefit across prespecified post-progression outcomes
If approved, patritumab deruxtecan would be a first-in-class HER3 directed DXd antibody drug conjugate for these patients
The initiation of the second clinical trial in the INTerpath program represents rapid expansion in research for additional tumor types for individualized neoantigen therapy, V940 (mRNA-4157)
In the Phase 3 LIBRETTO-431 study, Retevmo more than doubled progression-free survival (PFS) compared to chemotherapy plus pembrolizumab in patients with advanced or metastatic rearranged during transfection (RET) fusion-positive non-small cell lung cancer (NSCLC)
Approval based on DESTINY-Lung02 results where AstraZeneca and Daiichi Sankyo’s Enhertu demonstrated a confirmed objective response rate of 49% and median duration of response of 16.8 months in previously treated patients
Tagrisso is projected to be a pivotal contributor to AstraZeneca’s portfolio
The companies will work with investigators to share the results with the scientific community
Opinion granted based on positive disease-free survival results from the Phase 3 KEYNOTE-091 trial
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