What are the approved indications for osimertinib?

Osimertinib is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor developed by AstraZeneca, also known as EGFR-TKI. The advent of this drug is undoubtedly a great blessing for patients with non-small cell lung cancer (NSCLC).

Osimertinib is a highly efficient and selective inhibitor of EGFR mutants. Its unique pharmacological effects enable it to effectively and selectively inhibit resistance mutations associated with EGFR-TKI. What is more worth mentioning is that osimertinib has also shown excellent efficacy in EGFR-mutated NSCLC cases with brain metastasis. Because of this, it has become a first-line or adjuvant drug option for patients with advanced EGFR-mutated NSCLC.

Recently, a new indication of osimertinib combined with chemotherapy was approved by the US FDA, which means that it can be used as the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 sensitive mutations. The approval of this indication is based on the excellent results of FLAURA 2, a global multi-center, open-label, randomized phase III clinical trial. This study showed that compared with osimertinib monotherapy, osimertinib combined with chemotherapy significantly prolonged the progression-free survival of patients, providing a new treatment strategy for this type of patients.

In addition, osimertinib has also been approved for a new indication in China, namely first-line treatment in combination with chemotherapy EGFR mutated advanced non-small cell lung cancer, which undoubtedly brings more treatment options to Chinese patients.

Osimertinib not only has an inhibitory effect on EGFR mutations, but its clinical performance also shows that osimertinib can significantly improve the quality of life and prolong survival of patients who develop resistance to traditional EGFR-TKI drugs such as gefitinib and erlotinib.

In general, osimertinib, with its unique pharmacological mechanism and significant clinical effect, occupies an important position in NSCLC treatment and brings new hope to many patients.