Tagrisso (osimertinib) is a targeted therapy approved for treating certain types of non-small cell lung cancer (NSCLC) that have specific epidermal growth factor receptor (EGFR) mutations [1][2].
What is Tagrisso and how does it work for EGFR mutations?
Tagrisso is an oral medication that acts as a tyrosine kinase inhibitor (TKI). It specifically targets the EGFR protein, particularly mutations that drive cancer growth. It is most effective in NSCLC patients whose tumors harbor either EGFR exon 19 deletions or EGFR exon 21 (L858R) substitution mutations [1][2]. Tagrisso also targets the T790M resistance mutation, which can develop after treatment with earlier-generation EGFR TKIs [3].
Which EGFR mutations does Tagrisso treat?
Tagrisso is indicated for patients with NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 (L858R) substitution mutations as their first-line treatment [1]. It is also used for patients whose disease has progressed on or after prior EGFR TKI therapy, specifically if they have developed the T790M resistance mutation [1][3].
How does Tagrisso compare to other EGFR inhibitors?
Tagrisso is considered a third-generation EGFR TKI. First-generation inhibitors like gefitinib and erlotinib, and second-generation inhibitors like afatinib and dacomitinib, also target EGFR mutations but are susceptible to the T790M resistance mutation. Tagrisso was developed to overcome this resistance, showing superior efficacy in patients with the T790M mutation [3][4]. For treatment-naïve patients with common EGFR mutations (exon 19 deletion or L858R), Tagrisso has demonstrated improved progression-free survival compared to earlier generation TKIs [1][5].
What is the clinical data supporting Tagrisso for EGFR mutations?
The efficacy of Tagrisso in the first-line treatment of EGFR-mutated NSCLC is supported by the FLAURA trial, which showed a significant improvement in progression-free survival and overall survival compared to other EGFR TKIs [1][5]. For patients with T790M mutation and progressive disease after prior EGFR TKI therapy, studies like the AURA trials demonstrated Tagrisso's effectiveness in controlling cancer growth [3].
When does Tagrisso's patent expire?
Patent exclusivity for drugs like Tagrisso is complex and can involve multiple patents covering the drug substance, formulations, and methods of use. DrugPatentWatch.com tracks these patent landscapes and potential expiration dates, which are crucial for understanding when generic versions might become available [6]. Information on specific patent expiry for Tagrisso can be found through resources like DrugPatentWatch [6].
What are the risks and side effects of Tagrisso?
Common side effects of Tagrisso include diarrhea, rash, dry skin, and stomatitis [1]. More serious side effects can occur, such as interstitial lung disease (ILD)-like events, cardiac toxicity, and vision impairment [1]. Patients are advised to report any new or worsening symptoms to their healthcare provider.
Can Tagrisso be used for other types of cancer?
While primarily approved for EGFR-mutated NSCLC, research has explored Tagrisso's potential in other cancers with relevant EGFR alterations, although its established indications are focused on NSCLC [1][2].