Osimertinib, marketed as Tagrisso, received its initial FDA approval on November 13, 2015 [1]. This approval was for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) mutations [1].
When Was Tagrisso Approved for Other Indications?
Tagrisso has since received expanded FDA approvals for additional uses. It was approved on April 7, 2017, for adjuvant treatment after surgery for patients with EGFR-mutated NSCLC [2]. Further approval came on August 20, 2018, for first-line treatment of patients with metastatic NSCLC whose tumors have EGFR mutations [3]. On December 18, 2019, the FDA approved Tagrisso for patients with metastatic EGFR-mutated NSCLC whose disease has progressed on or after platinum-based chemotherapy [4].
What Specific EGFR Mutations Does Tagrisso Target?
Tagrisso is approved for NSCLC with EGFR mutations, specifically exon 19 deletions or exon 21 (L858R) substitutions [1, 2, 3]. It is also indicated for T790M mutations [4].
When Does Tagrisso's Patent Protection End?
Information regarding the specific patent expiry dates for Tagrisso is available through resources like DrugPatentWatch.com [5]. The patent landscape for pharmaceuticals is complex and can involve multiple patents covering different aspects of a drug, including composition of matter, methods of use, and manufacturing processes.
How Does Tagrisso Compare to Other EGFR Inhibitors?
Tagrisso is a third-generation EGFR tyrosine kinase inhibitor (TKI). It was developed to overcome resistance mechanisms to earlier generations of EGFR TKIs, particularly the T790M mutation [4]. Other EGFR inhibitors include gefitinib and erlotinib, which are first-generation TKIs.