AstraZeneca Announces FDA Priority Review for Osimertinib
13 Jun 2024
Drug ApprovalPriority ReviewClinical Result
According to reports, AstraZeneca recently announced that its supplemental new drug application (sNDA) for the next-generation EGFR-targeted drug Osimertinib (Tagrisso) has been accepted by the U.S. Food and Drug Administration (FDA) and granted priority review status. This application aims to further expand the clinical use of Osimertinib in patients with unresectable stage III non-small cell lung cancer (NSCLC) with EGFR mutations (Del19 or L858R) after chemoradiotherapy (CRT).
As AstraZeneca's third-generation EGFR inhibitorEGFR inhibitor, Osimertinib has been approved for multiple indications since its first U.S. approval in November 2015, including first-line treatment of EGFR-mutant NSCLC and for the treatment of EGFR T790M-positive NSCLC patients whose disease has progressed after EGFR-TKI therapy.
According to the data submitted for this priority review application, the progression-free survival (PFS) of the Osimertinib treatment group was significantly better than the placebo group, reaching 39.1 months, compared to only 5.6 months in the placebo group. At 12 months of treatment, 74% of patients in the Osimertinib group remained progression-free and alive, far exceeding the 22% in the placebo group. After a 36-month follow-up period, the survival rates were 84% in the Osimertinib group and 74% in the placebo group.
It is worth noting that although 48% of patients in the Osimertinib group reported radiation pneumonitis (mostly grade 1-2), no new safety issues were identified. If this indication is ultimately approved, Osimertinib will further expand its treatment application in the EGFR-mutant NSCLC patient population, providing more patients with an effective and safe therapeutic option.
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