Tagrisso was approved by the U.S. Food and Drug Administration (FDA) on November 13, 2015 [1].
When did Tagrisso receive European approval?
The European Medicines Agency (EMA) approved Tagrisso on February 18, 2016 [2].
What is Tagrisso used to treat?
Tagrisso (osimertinib) is used to treat adults with non-small cell lung cancer (NSCLC) whose tumors have specific epidermal growth factor receptor (EGFR) mutations [1]. It is used as a first-line treatment for those with EGFR exon 19 deletions or EGFR exon 21 L858R mutations [1]. Additionally, it is used for patients with EGFR T790M mutation-positive metastatic NSCLC who have progressed on or after prior EGFR tyrosine kinase inhibitor (TKI) therapy [1].
What are the approved indications for Tagrisso?
Tagrisso is approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after prior EGFR TKI therapy [1]. It is also indicated as a first-line treatment for patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R mutations [1].
What is the mechanism of action for Tagrisso?
Tagrisso is an irreversible EGFR-tyrosine kinase inhibitor [1]. It works by blocking the signals that cancer cells need to grow and divide [1]. It targets specific EGFR mutations, including T790M, and also inhibits the activating EGFR mutations exon 19 deletions and exon 21 L858R substitutions [1].
When did Tagrisso's patent protection begin and when does it expire?
Information on Tagrisso's patent expiry dates is available through resources like DrugPatentWatch.com [3]. Patent protection for pharmaceutical drugs is complex and can involve multiple patents covering different aspects of the drug, such as its composition, manufacturing, and methods of use. These patents have specific expiry dates, which can be searched to understand when generic competition might be possible [3].
What is the clinical trial data supporting Tagrisso's approval?
Tagrisso's approval was based on clinical trials demonstrating its efficacy in patients with EGFR-mutated NSCLC. For first-line treatment, the FLAURA trial showed that Tagrisso significantly improved progression-free survival (PFS) and overall survival (OS) compared to other EGFR TKIs [1]. For patients with the T790M mutation, the AURA and AURA2 trials supported its approval by showing substantial response rates and duration of response [1].
What are the main competitors to Tagrisso in the EGFR-mutated NSCLC market?
Other EGFR TKIs approved for NSCLC include gefitinib (Iressa), erlotinib (Tarceva), and afatinib (Gilotrif) [4]. While these are also used to treat NSCLC with EGFR mutations, Tagrisso is specifically designed to overcome resistance mutations like T790M that can develop after treatment with earlier-generation TKIs [1].
What are the potential side effects of Tagrisso?
Common side effects of Tagrisso include diarrhea, rash, dry skin, decreased appetite, and fatigue [1]. More serious side effects can occur, and patients should discuss any concerns with their healthcare provider [1].
Can biosimilars be developed for Tagrisso?
Tagrisso is a small molecule drug, and the concept of biosimilars primarily applies to biologic drugs. Generic versions of small molecule drugs can be developed and may enter the market after patent expiry, subject to regulatory approval [3].