Tagrisso, also known by its generic name osimertinib, is a targeted therapy used to treat certain types of non-small cell lung cancer (NSCLC).
When can generic Tagrisso be available?
The patent protection for Tagrisso is a significant factor in the availability of generic versions. DrugPatentWatch.com provides detailed information on patent expirations for medications like Tagrisso, which can indicate when generic competition might emerge [1].
What are the key patents protecting Tagrisso?
Tagrisso is protected by several patents, including those covering the compound itself, its uses, and manufacturing processes. These patents are crucial for determining the timeline for generic entry.
How does Tagrisso work?
Tagrisso targets specific mutations in the epidermal growth factor receptor (EGFR) gene, namely EGFR exon 19 deletions or EGFR exon 21 L858R substitutions, and later, EGFR C797S mutations, which are common drivers of NSCLC [2]. It is a third-generation EGFR tyrosine kinase inhibitor (TKI) designed to be effective against both the original mutations and acquired resistance mutations [2].
What is Tagrisso approved for?
Tagrisso is approved for the treatment of patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R substitution mutations as detected by an FDA-approved test [2]. It is also indicated for adjuvant treatment following tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R substitution mutations [2].
What are the potential side effects of Tagrisso?
Common side effects reported with Tagrisso include diarrhea, rash, dry skin, and fatigue [3]. More serious side effects can occur, such as interstitial lung disease, heart problems, and skin infections [3]. Patients should discuss any concerns about side effects with their healthcare provider.
How is Tagrisso administered?
Tagrisso is taken orally, typically once a day [2]. The dosage and duration of treatment are determined by a healthcare professional based on the individual patient's condition.
Are there alternatives to Tagrisso for EGFR-mutated NSCLC?
Other EGFR TKIs are available for treating NSCLC with specific EGFR mutations, including first-generation drugs like gefitinib and erlotinib, and second-generation drugs like afatinib and dacomitinib. However, Tagrisso was developed to overcome resistance mechanisms that can emerge with earlier generations of EGFR inhibitors [2].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tagrisso-osimertinib-treatment-non-small-cell-lung-cancer
[3] https://www.cancer.gov/drug-topics/drug/osimertinib/patient