FDA Approves AstraZeneca's Tagrisso (Osimertinib) for Unresectable EGFR-Mutated Stage III NSCLC with 84% Reduction in Disease Progression Risk

Sep 26, 2024 12:41 CST Updated 12:41

AstraZeneca

Biopharmaceutical Manufacturer

Source: PharmaCube Info

On September 25, the FDA's official website showed that AstraZeneca's Tagrisso (Osimertinib) was approved for a new indication, used to treatWithout disease progression during or after concurrent or sequential platinum-based chemoradiotherapy (CRT)Unresectable EGFR-mutated (exon 19 deletion or exon 21 L858R mutation)Phase IIIPatients with non-small cell lung cancer (NSCLC).

FDA Approval Based on Positive Results of Phase III LAURA Study (n=216). The results showed that the progression-free survival (PFS) of patients in the osimertinib group was significantly longer than that in the placebo group (39.1 vs. 5.6 months, HR=0.16, P<0.001); at 12 months, 74% of patients in the osimertinib group were alive and disease-free, compared to 22% in the placebo group; at 36 months, 84% and 74% of patients in the osimertinib and placebo groups, respectively, were still alive (HR=0.81, P=0.53, data maturity 20%).

In terms of safety,Osimertinib group and placebo group occurredThe proportions of grade 3 or higher adverse events were 35% and 12%, respectively. Additionally,In the osimertinib group, 48% of patients reported radiation pneumonitis (mainly grade 1-2), compared to 38% in the placebo group.No new safety issues were identified.

Osimertinib is a third-generation EGFR inhibitor developed by AstraZeneca, which was first approved for marketing in the United States in November 2015.As of now, the drug has been approved for 5 indications:

1) MonotherapyFrontlineTreatmentExon 19 deletion or exon 21 L858R mutationPatients with locally advanced or metastatic NSCLC;

2）AcceptDuring or after EGFR-TKI treatmentDisease progressionEGFR T790M Mutation PositivePatients with locally advanced or metastatic NSCLC;

3）Adjuvant TherapyAfter surgical resectionExon 19 deletion or exon 21 L858R mutationPatients with NSCLC;

4) Combination use of Pemetrexed andPlatinum-based ChemotherapyFrontlineTreatmentExon 19 deletion or exon 21 L858R mutationPatients with locally advanced or metastatic NSCLC;

5）Without disease progression during or after concurrent or sequential platinum-based chemoradiotherapy (CRT)Unresectable EGFR-mutated (Exon 19 deletion or Exon 21 L858R mutation)Stage III NSCLCPatient.

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