Shots:

• The NMPA’s approval follows its PR pathway and is based on P-III FLAURA study assessing Tagrisso (80mg- qd) vs EGFR-TKIs (erlotinib [150mg- qd]/gefitinib [250mg- qd]) in 556 previously untreated patients with LA/m- EGFR mutated NSCLC across 29 countries
•  The P-III FLAURA study results: improvement in PFS (18.9 vs 10.2mos.); ORR (77% vs 69%); CR (2% vs 1%); Partial response (75% vs 68%); median DoR (17.6 vs 9.6mos.); AEs (34% vs 45%)
• Tagrisso is an irreversible EGFR-TKI- inhibiting both EGFR-sensitizing         and EGFR T790M-resistance mutations and has received NMPA’s approval in Mar’2017 and added to the NRD list effective from Jan’2019 as 2L therapy for LA/m- EGFR T790M mutated NSCLC with a progressed disease on or after EGFR-TKI therapy

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Ref: AstraZeneca | Image: Pharmacy Business