AstraZeneca Submits New Osimertinib Indication for Marketing Approval in China

On September 21, the CDE website showed that AstraZeneca's new indication application for Osimertinib has been accepted.

Osimertinib is an irreversible third-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) with clinical activity against CNS metastases. The product has three approved indications in China: 1) For adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed on or after prior treatment with an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) and whose tumors have been confirmed to harbor the EGFR T790M mutation; 2) For first-line treatment of NSCLC patients with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations; 3) For adjuvant treatment in adult patients with EGFR mutation-positive NSCLC following tumor resection.

Since its launch in 2015, Osimertinib has shown strong market performance. The product’s annual sales exceeded $5 billion in 2021, and reached as high as $2.915 billion in the first half of this year, mainly due to the expansion of its indications for adjuvant treatment of early-stage lung cancer.

In May this year, AstraZeneca announced positive results from the Phase III FLAURA2 study of osimertinib combined with chemotherapy for the treatment of EGFR-mutated NSCLC, with PFS showing statistically significant and clinically meaningful improvement. The specific data were presented at the 2023 World Conference on Lung Cancer (WCLC). Compared with osimertinib monotherapy, the investigator-assessed osimertinib plus chemotherapy extended median PFS by 8.8 months, while the blinded independent central review committee (BICR)-assessed osimertinib plus chemotherapy group extended median PFS by 9.5 months.

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