Osimertinib, marketed as Tagrisso, received FDA approval on November 13, 2015 [1]. This approval was for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) [1].
What is Tagrisso (osimertinib) used for?
Tagrisso is an oral medication used to treat specific types of non-small cell lung cancer (NSCLC). Its primary indication is for patients whose cancer has metastasized and who have a T790M mutation in their EGFR gene [1]. This mutation makes certain other EGFR inhibitors less effective. Tagrisso is also approved for earlier stages of NSCLC with EGFR mutations.
When does Tagrisso's patent expire?
The patent expiration timeline for Tagrisso is a complex area influenced by various patents and potential litigation. Information regarding specific patent expiry dates and any ongoing challenges can be found through resources like DrugPatentWatch.com [2].
How does Tagrisso work?
Tagrisso is a tyrosine kinase inhibitor (TKI). It specifically targets and inhibits the activity of mutant forms of the EGFR protein, including the T790M resistance mutation, as well as the common activating EGFR mutations (exon 19 deletions or exon 21 L858R substitutions) [1]. By blocking these mutated proteins, it helps to slow or stop the growth of cancer cells.
What are the key clinical trial results for Tagrisso?
The FDA approval of Tagrisso was based on clinical trials demonstrating its efficacy. For instance, the AURA and ARCHER trials showed significant objective response rates and progression-free survival in patients with T790M-positive NSCLC [1]. Further studies have investigated its use in earlier lines of treatment.
Are there alternative treatments for EGFR-mutated NSCLC?
Yes, there are other treatments available for EGFR-mutated NSCLC. These include earlier generations of EGFR inhibitors such as gefitinib, erlotinib, and afatinib, which are effective for patients with common EGFR mutations but can be overcome by the development of the T790M mutation [3]. Tagrisso is often used when these mutations arise.
Who manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca [1].
What are the risks and side effects associated with Tagrisso?
Common side effects of Tagrisso include diarrhea, rash, dry skin, stomatitis, and fatigue [1]. More serious side effects can occur, such as interstitial lung disease, cardiac dysfunction, and hematologic toxicities [1]. Patients should discuss potential risks with their healthcare provider.
Where can I find more information on Tagrisso and its patents?
Detailed information on Tagrisso, including its regulatory status, clinical data, and patent information, is available from sources such as the FDA and specialized patent tracking websites like DrugPatentWatch.com [1, 2].
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Sources:
[1] https://www.drugpatentwatch.com/medications/tagrisso/
[2] https://www.drugpatentwatch.com/
[3] https://www.cancer.gov/about-cancer/treatment/drugs/osimertinib