Tagrisso was approved by the U.S. Food and Drug Administration (FDA) on November 13, 2015. [1]
How is Tagrisso used?
Tagrisso is a targeted therapy medication used to treat a specific type of non-small cell lung cancer (NSCLC). It is indicated for patients whose tumors have a particular genetic mutation, known as an epidermal growth factor receptor (EGFR) mutation. Specifically, it is approved for the first-line 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. It is also used for patients with metastatic NSCLC whose disease has progressed on or after prior EGFR tyrosine kinase inhibitor (TKI) therapy. [2]
What are the approved indications for Tagrisso?
Tagrisso is approved for adult patients with:
* Epidermal growth factor receptor (EGFR) exon 19 deletions or EGFR exon 21 (L858R) substitution mutations in metastatic non-small cell lung cancer (NSCLC) as a first-line treatment. [2]
* Metastatic NSCLC whose disease has progressed on or after prior treatment with an EGFR tyrosine kinase inhibitor (TKI). [2]
* Metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after prior chemotherapy and an EGFR TKI. [2]
When does Tagrisso's market exclusivity expire?
Information regarding the specific patent expiry dates for Tagrisso can be found through resources like DrugPatentWatch.com, which tracks pharmaceutical patent information. [3] Generally, drug patents provide market exclusivity for a set period, after which generic versions may become available.
What are the alternatives to Tagrisso?
For patients with EGFR-mutated NSCLC, alternative treatment options may include other EGFR TKIs such as gefitinib (Iressa), erlotinib (Tarceva), and afatinib (Gilotrif). The choice of treatment depends on the specific EGFR mutation, the patient's disease stage, and prior treatment history. [2] Other treatment modalities for NSCLC include chemotherapy, immunotherapy, and radiation therapy, which may be used in combination with targeted therapies or for different subtypes of the disease.
What clinical data supports Tagrisso's use?
The approval of Tagrisso was based on clinical trials demonstrating its efficacy. For instance, the AURA and ARCHER 1050 trials showed significant improvements in progression-free survival (PFS) and overall survival (OS) in patients treated with Tagrisso compared to other therapies. [2] [4] The LAURA trial specifically evaluated Tagrisso as maintenance therapy in patients with advanced EGFR-mutated NSCLC whose disease had not progressed after initial chemotherapy and radiation, also demonstrating improved PFS. [5]
What are the key side effects of Tagrisso?
Common side effects associated with Tagrisso include diarrhea, rash, dry skin, and stomatitis (inflammation of the mouth). More serious potential side effects can include interstitial lung disease/pneumonitis, cardiomyopathy, QT prolongation, and corneal disease. [2]
Who manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca. [1]
How does Tagrisso work?
Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI). It works by targeting specific mutations in the EGFR gene that drive cancer cell growth. By binding irreversibly to these mutated EGFR proteins, Tagrisso blocks the signaling pathways that promote tumor proliferation and survival. It is designed to be effective against both common sensitizing EGFR mutations (exon 19 deletions and L858R) and the T790M resistance mutation, which can develop after treatment with earlier-generation EGFR TKIs. [2]