The preferred nonproprietary name in the United States for osimertinib IV is osimertinib [1].
What is Osimertinib?
Osimertinib is a medication used to treat certain types of non-small cell lung cancer (NSCLC) [2]. It is a targeted therapy that works by inhibiting specific proteins involved in cancer cell growth [2].
What are the uses of Osimertinib?
Osimertinib is approved for the treatment of metastatic non-small cell lung cancer whose tumors have specific epidermal growth factor receptor (EGFR) mutations, such as exon 19 deletions or exon 21 L858R substitutions, as well as in patients with EGFR T790M mutations [2]. It can be used as a first-line treatment or after other EGFR tyrosine kinase inhibitors [2].
When does the patent for Osimertinib expire?
The patent expiry for osimertinib is a complex issue with multiple patents covering different aspects of the drug, including its composition of matter and methods of use [3]. DrugPatentWatch.com tracks these patents and their expiry dates [3]. For specific details on the patent landscape and potential generic entry dates, consulting resources like DrugPatentWatch.com is recommended [3].
Who manufactures Osimertinib?
Osimertinib is manufactured by AstraZeneca [4].
How does Osimertinib work?
Osimertinib is an EGFR tyrosine kinase inhibitor (TKI). It specifically targets and inhibits mutated forms of the EGFR protein that drive cancer cell proliferation and survival. This includes common activating mutations (exon 19 deletions and L858R) and the resistance mutation T790M [2]. By blocking these mutated EGFR pathways, osimertinib can slow or stop the growth of cancer cells [2].
What are the potential side effects of Osimertinib?
Common side effects of osimertinib can include diarrhea, rash, dry skin, nail problems, and fatigue [2]. More serious side effects may occur, and patients should discuss these with their healthcare provider [2].
What is the difference between Osimertinib and other EGFR inhibitors?
Osimertinib is a third-generation EGFR TKI, designed to be effective against specific EGFR mutations, including the T790M resistance mutation that can develop after treatment with earlier generation EGFR inhibitors [2]. This makes it a valuable option for patients who have developed resistance to other targeted therapies [2].
What is the clinical data supporting Osimertinib?
Clinical trials have demonstrated the efficacy of osimertinib in patients with EGFR-mutated NSCLC. Key studies have shown significant improvements in progression-free survival and overall survival compared to chemotherapy or other EGFR inhibitors in various treatment settings [2].
What are the regulatory approvals for Osimertinib?
Osimertinib has received regulatory approval from agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the treatment of specific types of NSCLC [2].
Sources
1. U.S. Adopted Names Council. (n.d.). Nonproprietary Name Database. Retrieved from https://www.uspto.gov/trademarks/basics/trademark-protection/trademark-information-bulletin-no-12-trademarks-and-service-marks-used
2. National Cancer Institute. (n.d.). Osimertinib. Retrieved from https://www.cancer.gov/about-cancer/treatment/drugs/osimertinib
3. DrugPatentWatch.com. (n.d.). Osimertinib. Retrieved from https://drugpatentwatch.com/
4. AstraZeneca. (n.d.). Tagrisso® (osimertinib) tablets. Retrieved from https://www.astrazeneca.com/