In a significant development for lung cancer treatment, the FDA has granted approval to AstraZeneca’s Tagrisso (osimertinib) for adult patients battling a specific and aggressive form of the disease. The approval covers patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). This means the cancer is inoperable and has not progressed after receiving concurrent or sequential platinum-based chemoradiation therapy (CRT).
Tagrisso is specifically indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, further highlighting the drug’s targeted approach. The approval is based on the results of the LAURA Phase 3 trial, which demonstrated Tagrisso’s efficacy in reducing the risk of disease progression or death by a remarkable 84% compared to a placebo. The median progression-free survival (PFS) for patients on Tagrisso was 39.1 months, significantly longer than the 5.6 months observed for those receiving placebo. While overall survival (OS) data remains immature, the trial is ongoing and will continue to assess OS as a secondary endpoint.
This approval comes at a critical time, as lung cancer continues to be a leading cause of cancer-related deaths in the US. Every year, over 200,000 individuals are diagnosed with lung cancer, with NSCLC accounting for 80-85% of these cases. Approximately 15% of NSCLC patients in the US harbor EGFR mutations, and nearly one in five individuals diagnosed with NSCLC have tumors that cannot be surgically removed.
The safety and tolerability of Tagrisso in the LAURA trial were consistent with its established profile, and no new safety concerns emerged. Tagrisso already holds approvals for patients with EGFR mutations in various settings, including first-line metastatic disease, as monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease.
This recent approval adds another layer of hope for patients facing this challenging diagnosis, offering a potentially life-extending treatment option for a specific subset of lung cancer patients. AstraZeneca’s Tagrisso continues to solidify its position as a leading force in the fight against lung cancer.
