Osimertinib was first approved by the U.S. Food and Drug Administration (FDA) on November 3, 2015 [1]. This initial 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—exon 19 deletions or exon 21 L858R substitutions—as detected by an FDA-approved test [1][2].
When did Osimertinib become available in other countries?
The European Medicines Agency (EMA) granted marketing authorization for osimertinib on February 10, 2016 [3]. Other regulatory bodies have also approved the drug, expanding its global availability.
What are the main uses for Osimertinib now?
Osimertinib is indicated for advanced or metastatic NSCLC with EGFR mutations [1][2]. It is used in two primary settings:
* As a first-line treatment for patients with EGFR-mutated NSCLC [4].
* For patients whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) [1][2].
What is the difference between first-line and later-line Osimertinib treatment?
First-line treatment with osimertinib is for patients who have not previously received therapy for advanced or metastatic NSCLC, provided their tumors harbor specific EGFR mutations [4]. Later-line treatment is for patients whose cancer has worsened after prior EGFR TKI therapy [1][2]. The efficacy and patient selection criteria can differ between these settings.
How does Osimertinib work?
Osimertinib is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI). It targets both sensitizing EGFR mutations (like exon 19 deletions and L858R) and the T790M resistance mutation, which is a common mechanism by which cancer cells become resistant to earlier-generation EGFR TKIs [1][5]. By blocking these mutated EGFR proteins, osimertinib inhibits tumor cell growth and survival [5].
When does patent protection for Osimertinib end?
Drug patent information for osimertinib can be complex and involves multiple patents covering various aspects of the drug, including composition of matter, methods of use, and formulations [6]. DrugPatentWatch.com tracks these patents and their expiry dates [6]. Specific patent expiry timelines are crucial for determining when generic or biosimilar versions may become available.
Who are the main competitors to Osimertinib?
Competitors to osimertinib include other EGFR TKIs used in NSCLC, such as gefitinib, erlotinib, and afatinib (first and second-generation TKIs), as well as other targeted therapies and immunotherapies depending on the specific mutation status and line of treatment [7]. The competitive landscape is also influenced by emerging treatments and potential generics.
What clinical trials support Osimertinib's approval?
Key clinical trials supporting osimertinib's approval include the AURA and FLAURA studies. The FLAURA trial demonstrated superior progression-free survival and overall survival for osimertinib compared to other EGFR TKIs in the first-line treatment setting [4]. The AURA studies evaluated its efficacy in patients who had progressed on prior therapies [1][2].
Sources:
[1] https://www.drugpatentwatch.com/drugs/osimertinib
[2] https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208070lbl.pdf
[3] https://www.ema.europa.eu/en/medicines/human/EPAR/tagrisso
[4] https://ascopubs.org/doi/full/10.1200/JCO.2017.76.0557
[5] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6552095/
[6] https://www.drugpatentwatch.com/
[7] https://www.cancer.gov/about-cancer/treatment/drugs/osimertinib