Tagrisso was launched in the United States in November 2015 [1]. The drug received its initial FDA approval in November 2015 for patients with EGFR-mutated metastatic non-small cell lung cancer who had progressed on or after platinum-based chemotherapy [2].
What is Tagrisso used for?
Tagrisso is an oral medication used to treat certain types of non-small cell lung cancer (NSCLC) with specific genetic mutations. It is approved for:
* First-line treatment of metastatic NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 (L858R) substitution mutations, as detected by an FDA-approved test [2].
* Treatment of metastatic EGFR T790M mutation-positive NSCLC whose disease has progressed on or after at least one prior EGFR tyrosine kinase inhibitor therapy [2].
When did Tagrisso get approved in other regions?
Tagrisso received marketing authorization from the European Medicines Agency (EMA) in February 2016 [3].
How does Tagrisso work?
Tagrisso is a tyrosine kinase inhibitor (TKI) that specifically targets and blocks the activity of certain mutated forms of the epidermal growth factor receptor (EGFR) protein. These mutations can drive the growth of cancer cells. By inhibiting these mutated EGFRs, Tagrisso helps to slow or stop cancer cell proliferation [4].
What are the potential side effects of Tagrisso?
Common side effects of Tagrisso include diarrhea, rash, dry skin, and inflammation of the mouth or gums [2]. More serious side effects can occur, such as interstitial lung disease, heart problems, and liver problems [2].
What is the patent status for Tagrisso?
The patent landscape for Tagrisso is complex, involving multiple patents covering the drug itself, its manufacturing processes, and its uses. Information on patent expiry dates and any ongoing litigation can be tracked through resources like DrugPatentWatch.com [5].
How does Tagrisso compare to other EGFR inhibitors?
Tagrisso is considered a third-generation EGFR inhibitor, designed to be effective against specific EGFR mutations that can lead to resistance against earlier generations of EGFR inhibitors, such as gefitinib and erlotinib [4]. It is also effective in treating T790M mutations, a common mechanism of acquired resistance [2].
Can Tagrisso be used in earlier stages of lung cancer?
Tagrisso's indication has expanded over time. In addition to its initial use in advanced or metastatic disease, it is now approved as a first-line treatment for patients with EGFR-mutated NSCLC [2].
What are the clinical trial results for Tagrisso?
Clinical trials have demonstrated significant improvements in progression-free survival and overall survival for patients treated with Tagrisso compared to chemotherapy or earlier EGFR inhibitors in specific patient populations [2][4].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/tagrisso-approved-november-2015
[2] https://www.fda.gov/drugs/drug-label-information/tagrisso-osimertinib
[3] https://www.ema.europa.eu/en/medicines/human/EPAR/tagrisso
[4] https://www.nejm.org/doi/full/10.1056/NEJMoa1713139
[5] https://drugpatentwatch.com/