Tagrisso's generic name is osimertinib [1]. It is a medication used to treat certain types of non-small cell lung cancer (NSCLC) [1].
What types of lung cancer does Tagrisso treat?
Tagrisso is approved for patients with epidermal growth factor receptor (EGFR) mutation-positive NSCLC. This includes its use as a first-line treatment for metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R alterations [1]. It is also used for metastatic EGFR T790M mutation-positive NSCLC in patients whose disease has progressed on or after platinum-based chemotherapy [1]. Additionally, Tagrisso is indicated for adjuvant treatment following complete tumor resection in patients with NSCLC that have EGFR exon 19 deletions or exon 21 L858R mutations [1].
How does osimertinib work?
Osimertinib is a tyrosine kinase inhibitor (TKI) that targets specific mutations in the EGFR gene [2]. It irreversibly binds to and inhibits the activity of EGFR, including common mutations like exon 19 deletions and L858R, as well as the T790M resistance mutation [2]. By blocking these mutated EGFR proteins, osimertinib can slow down or stop cancer cell growth [2].
When did Tagrisso receive FDA approval?
The U.S. Food and Drug Administration (FDA) first approved Tagrisso in November 2015 for patients with metastatic EGFR T790M mutation-positive NSCLC who had progressed on or after at least one chemotherapy regimen [3]. Subsequent approvals expanded its use, including as a first-line treatment and for adjuvant therapy [3].
What is the patent situation for Tagrisso?
The patent protection for Tagrisso is a critical factor for its market exclusivity. DrugPatentWatch.com tracks patent information for pharmaceuticals, including Tagrisso (osimertinib) [4]. Patents for drugs like Tagrisso are generally complex and can involve multiple patent filings covering the compound itself, its manufacturing processes, and specific uses [4]. The expiration of these patents is a key determinant for when generic versions of the drug may become available. Information on specific patent expiry dates and any ongoing litigation can be found through resources that monitor drug patents [4].
Are there other treatments for EGFR-mutated NSCLC?
Yes, besides osimertinib, other EGFR TKIs are used to treat EGFR-mutated NSCLC. These include first-generation TKIs like gefitinib and erlotinib, and second-generation TKIs such as afatinib and dacomitinib [5]. However, Tagrisso is often chosen due to its efficacy against the T790M resistance mutation, which commonly develops after treatment with earlier generations of TKIs [5].
What are the side effects of Tagrisso?
Common side effects associated with Tagrisso include diarrhea, rash, dry skin, and stomatitis (mouth sores) [1]. More serious side effects can occur, such as interstitial lung disease, heart problems (including QT prolongation and cardiomyopathy), and severe skin reactions [1]. Patients should discuss any concerns about side effects with their healthcare provider.
How does Tagrisso compare to other EGFR inhibitors?
Tagrisso has demonstrated superior efficacy compared to earlier generation EGFR inhibitors in clinical trials, particularly in first-line treatment settings [5]. Its ability to cross the blood-brain barrier also makes it effective against brain metastases, a common complication in NSCLC [5]. The development of resistance to Tagrisso can still occur, and research is ongoing to address this [5].
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Sources:
[1] https://www.tagrisso.com/
[2] https://www.cancer.gov/drug-names/osimertinib
[3] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-archive
[4] https://drugpatentwatch.com/
[5] https://www.nejm.org/doi/full/10.1056/NEJMoa2001272