United Kingdom-based AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor mutations, it was reported yesterday.
The approval is based on results from the Phase III FLAURA trial, which were revealed at the European Society of Medical Oncology 2017 Congress. The FLAURA trial compared Tagrisso to current 1st-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib, in earlier-untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer.
The product met the primary endpoint of progression-free survival. Progression-Free Survival results with Tagrisso were consistent across all pre-specified patient subgroups, including in patients with or without central nervous system metastases. Overall survival data were not mature at the time of the final Progression-Free Survival analysis. Safety data for the product in the FLAURA trial were in line with those observed in prior clinical trials.
D3 Bio announces Series A+ Round completion to advance innovative oncology pipeline
Dizal's sunvozertinib receives US FDA Breakthrough Therapy Designation
Merck launches Phase 3 trial of MK-1084 and KEYTRUDA combination in metastatic NSCLC
Genprex increases sites for Acclaim-3 clinical trial
Trevi Therapeutics names new vice president of Clinical Development
Personalis validates NeXT Personal test for ultra-sensitive MRD detection
Merck reports lung cancer trial failed to meet endpoints
BerGenBio ASA starts Phase 2a portion of BGBC016 clinical study of bemcentinib