AstraZeneca (AZ; NASDAQ: AZN), a UK-based pharmaceutical company, has announced that it has received another indication approval from China’s National Medical Products Administration (NMPA) for its drug Tagrisso (osimertinib), an EGFR-tyrosine kinase inhibitor (EGFR-TKI). The drug is now approved for use in combination with chemotherapy as a first-line treatment for locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) with exon 19 deletions or exon 21 mutations.
The approval follows the positive results from the global, multi-center Phase III FLAURA2 study. Data from the global cohort indicated that the combination of osimertinib with chemotherapy, compared to osimertinib alone, reduced the risk of disease progression or death by 38% and prolonged median progression-free survival (mPFS) by 8.8 months (25.5 months vs. 16.7 months). The combination therapy demonstrated good safety. The efficacy and safety profiles of the Chinese cohort were consistent with the global cohort, showing a 44% reduction in the risk of disease progression or mortality in the combination therapy group.
Tagrisso has received several approvals in China, including for second-line treatment of NSCLC that has progressed after previous EGFR-TKI treatment and has an EGFR T790M mutation, first-line treatment of EGFR-mutated NSCLC with exon 19 deletions or exon 21 mutations, adjuvant therapy for EGFR-mutated stage IB-IIIA NSCLC with exon 19 deletions or exon 21 mutations post-curative surgery, and now in combination with chemotherapy for first-line treatment of EGFR-mutated NSCLC with exon 19 deletions or exon 21 mutations.- Flcube.com
