Medicosnext
The recent FDA approval of a groundbreaking therapy with Osimertinib has transformed the landscape of non-small cell lung cancer (NSCLC) treatment. Osimertinib, known by its brand name Tagrisso, in combination with chemotherapy, has received the regulatory nod for the treatment of locally advanced or metastatic Epidermal Growth Factor Receptor EGFR-mutated NSCLC. This milestone decision is anchored in the compelling results of the phase 3 FLAURA2 trial (NCT04035486).
Osimertinib belongs to a class of drugs known as tyrosine kinase inhibitors, which work by blocking signals that promote the growth of cancer cells. Initially approved as a monotherapy for locally advanced or metastatic EGFR-mutated NSCLC, its recent FDA approval in combination with chemotherapy represents a milestone. The FLAURA2 trial has demonstrated a 38% reduction in the risk of disease progression or death when Osimertinib was combined with chemotherapy. The impressive improvement in progression-free survival was emphasized by Dr. Joshua Sabari, a key investigator, who highlighted the median PFS extension by 8.8 months compared to osimertinib monotherapy. This advantage was consistently observed across patient subgroups, including those with central nervous system metastases.
The FDA’s approval extends the usage of osimertinib, which was already approved as a monotherapy for various NSCLC indications. The breakthrough therapy designation granted in August 2023 underscores the therapeutic potential of osimertinib plus chemotherapy in this patient population. The manageable safety profile of the combination, despite a higher incidence of grade 3 or higher adverse events is noteworthy. Importantly, the responses in the combination arm surpassed those in the monotherapy arm, with a higher percentage of complete or partial responses and an extended median response duration. The FLAURA2 trial marks a significant step forward in the pursuit of improved treatment options for EGFR-mutated NSCLC, providing hope for enhanced outcomes and better quality of life for patients facing this challenging diagnosis. This approval signals a promising future for the integration of targeted therapies and chemotherapy in the evolving landscape of lung cancer treatment.
Reference: https://www.targetedonc.com/view/fda-oks-osimertinib-plus-chemo-in-egfr-mutant-lung-cancer
