Tanja Obradovic: FDA just approved Osimertinib for adult patients with locally advanced, unresectable non-small cell lung cancer

Tanja Obradovic shared a post on LinkedIn:

”FDA just approved Osimertinib (Tagrisso), a third-generation EGFR-directed tyrosine kinase inhibitor (TKI), for adult patients with locally advanced, unresectable (stage III) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations. Community expected this positive outcome after what we have seen at ASCO 2024 from LAURA trial. Interesting to note is that approval is granted despite immature OS since 36% of pre-specified deaths for the final analysis were reported and no trend towards a detriment was observed.

This is label expansion for Osimertinib as FDA previously granted approval for the first line treatment of adults with advanced or metastatic EGFR-mutant NSCLC or as adjuvant therapy for resectable EGFR-mutant NSCLC.”

Source: Tanja Obradovic/LinkedIn

Tanja Obradovic is the Vice President of Oncology Scientific Affairs at ICON PLCh. She has over 20 years of clinical research experience and has led major pharmaceutical companies for 13 years. Her research focuses on small molecules, antibodies, cell and gene therapy, and major immunotherapy of PD1 inhibitors.