Accelerating FDA submission and confirming potential to become first approved biologic for this serious disease
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)
The companies will work with investigators to share the results with the scientific community
KEYTRUDA plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS versus concurrent chemoradiotherapy alone in these patients
Data support that antibiotic aztreonam-avibactam (ATM-AVI) is effective and well-tolerated in treating infections caused by Gram-negative bacteria, with a similar safety profile to aztreonam alone
This is the first time the Agency has authorized the Phase 3 clinical evaluation in the U.S of a microbiota-based live biotherapeutic based on a pooling technology
The Phase 3 data presented at AAD include a comprehensive review of the THRIVE-AA2 results and further elaborate the topline data reported in August 2022
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
Data build on previously reported results from the primary endpoint of investigator-assessed radiographic progression-free survival
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