FDA Grants Priority Review to Osimertinib, AstraZeneca Reports

AstraZeneca has recently announced a significant advancement for its next-generation EGFR-targeted drug, Osimertinib (Tagrisso). The U.S. Food and Drug Administration (FDA) has accepted AstraZeneca's supplemental new drug application (sNDA) for Osimertinib and granted it priority review status. This application aims to broaden the clinical use of Osimertinib in treating patients with unresectable stage III non-small cell lung cancer (NSCLC) that harbor EGFR mutations (Del19 or L858R), particularly following chemoradiotherapy (CRT).

Osimertinib, a third-generation EGFR inhibitor, has been a crucial part of AstraZeneca's oncology portfolio since its initial approval by the FDA in November 2015. The drug has been approved for various indications, including the first-line treatment of EGFR-mutant NSCLC and for patients with EGFR T790M-positive NSCLC whose disease has advanced after EGFR-TKI therapy.

The data submitted for this priority review highlight the efficacy of Osimertinib in improving progression-free survival (PFS) among patients. The results are compelling: the Osimertinib treatment group achieved a median PFS of 39.1 months, in stark contrast to just 5.6 months in the placebo group. At the 12-month mark, 74% of patients in the Osimertinib group were still progression-free and alive, compared to only 22% in the placebo group. Further, a 36-month follow-up showed survival rates of 84% for the Osimertinib group versus 74% for those on the placebo.

An important aspect of the study was the safety profile of Osimertinib. While 48% of patients in the Osimertinib group reported cases of radiation pneumonitis, mostly of grade 1-2 severity, no new safety concerns emerged. This suggests that Osimertinib maintains a favorable safety profile even with prolonged use.

If the FDA approves this new indication, Osimertinib will be available to a wider patient population with EGFR-mutant NSCLC, offering these patients a more effective and safer treatment option. This expansion could significantly impact the treatment landscape for NSCLC, providing hope and improved clinical outcomes for a broader array of patients.