See the DrugPatentWatch profile for Osimertinib
Osimertinib, marketed as Tagrisso, received its initial FDA approval on November 13, 2015 [1]. This 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 [1].
What are the specific EGFR mutations approved for Osimertinib?
The initial FDA approval was for patients with EGFR exon 19 deletions or EGFR exon 21 L858R substitution mutations [1]. Later approvals expanded its use to include other scenarios.
When was Osimertinib approved for other indications?
Osimertinib's approval has been extended to cover additional patient populations and disease stages. It was approved for the first-line treatment of patients with metastatic EGFR-mutated NSCLC on April 18, 2018 [2]. Further approvals included the adjuvant treatment of patients with NSCLC whose tumors have an EGFR exon 19 deletion or EGFR exon 21 L858R substitution after surgical resection on April 18, 2020 [3]. In December 2020, it was approved for patients with metastatic NSCLC whose tumors have an EGFR T790M mutation and who have progressed on or after chemotherapy [4]. Most recently, on February 1, 2023, it received approval for the first-line treatment of adult patients with locally advanced or metastatic NSCLC presenting with EGFR exon 19 deletions or EGFR exon 21 (L858R) substitutions [5].
Who manufactures Osimertinib?
Osimertinib is manufactured by AstraZeneca [1].
What are the clinical trial results supporting Osimertinib's approval?
The initial approval was based on clinical trials demonstrating significant response rates and duration of response in patients with EGFR-mutated NSCLC [1]. Subsequent approvals have been supported by data showing improved progression-free survival and overall survival in various treatment settings, including first-line therapy and adjuvant settings [2][3][4][5]. For example, the FLAURA trial demonstrated superior progression-free survival and overall survival for osimertinib compared to other EGFR tyrosine kinase inhibitors in the first-line treatment of metastatic EGFR-mutated NSCLC [2].
When does the patent for Osimertinib expire?
Drug patent information, including expiry dates, can be complex and subject to change due to various factors like patent extensions and challenges. For the most up-to-date and detailed patent expiry information for Osimertinib, consulting resources like DrugPatentWatch.com is recommended [6].
What are the potential risks or side effects associated with Osimertinib?
Common side effects reported for Osimertinib include diarrhea, rash, dry skin, and stomatitis [1]. More serious adverse events have also been observed, and patients should discuss potential risks with their healthcare provider.
Are there any generic alternatives to Osimertinib?
Currently, there are no generic versions of Osimertinib available in the market. Generic versions typically become available after the patent protection for the brand-name drug expires and regulatory approval is granted for the generic product.
How does Osimertinib work?
Osimertinib is a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI). It is designed to target specific EGFR mutations, including the T790M resistance mutation, as well as sensitizing mutations, thereby blocking tumor cell signaling pathways that drive cancer growth [1][4].
Sources:
1. https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/208065s000lbl.pdf
2. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tagrisso-osimertinib-first-line-treatment-patients-epidermal-growth-factor-receptor-egfr
3. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tagrisso-osimertinib-adjuvant-treatment-non-small-cell-lung-cancer
4. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tagrisso-osimertinib-patients-metastatic-non-small-cell-lung-cancer-egfr-t790m-mutation
5. https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tagrisso-osimertinib-first-line-treatment-non-small-cell-lung-cancer
6. https://drugpatentwatch.com/