Osimertinib, marketed as Tagrisso, received FDA approval in 2015 for specific types of non-small cell lung cancer [1].
What is Tagrisso approved for?
Tagrisso is indicated for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC) whose disease has progressed on or after a prior EGFR tyrosine kinase inhibitor (TKI) therapy [1].
How does Tagrisso work?
Tagrisso is a third-generation EGFR tyrosine kinase inhibitor (TKI). It selectively targets both sensitizing EGFR mutations and the T790M resistance mutation. By inhibiting these mutated EGFRs, Tagrisso blocks downstream signaling pathways that promote cancer cell growth and survival [1].
When did the FDA approve Tagrisso?
The U.S. Food and Drug Administration (FDA) approved Tagrisso on November 13, 2015 [1].
What are the clinical trial results supporting Tagrisso's approval?
The FDA approval was based on findings from the AURA study, which demonstrated significant objective response rates and durable responses in patients with EGFR T790M mutation-positive NSCLC who had progressed on prior EGFR TKI therapy [1].
Are there other FDA approvals for Tagrisso?
Yes, Tagrisso has received subsequent approvals for other indications. In 2017, it was approved for the first-line treatment of patients with metastatic EGFR-mutated NSCLC [2]. In 2020, it gained approval for extended adjuvant treatment of patients with EGFR exon 19 deletion or EGFR exon 21 L858R substitution mutations as their primary treatment after tumor resection [3].
What is the patent status for Tagrisso?
Information on drug patents, including those for Tagrisso, is available from resources like DrugPatentWatch.com [4]. Patents protect the exclusivity of a drug and influence when generic versions can enter the market.
Who manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca [1].