Tagrisso (osimertinib) received FDA approval on November 13, 2015, 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 Tagrisso targets?
Tagrisso is approved for NSCLC patients with EGFR exon 19 deletions or EGFR exon 21 (L858R) substitution mutations [1]. It is also effective against the T790M resistance mutation [2].
When did Tagrisso get approval for other indications?
Tagrisso's approval has expanded to include other indications. It received accelerated approval on April 14, 2017, for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after prior EGFR tyrosine kinase inhibitor (TKI) therapy [2]. Further approval was granted on March 18, 2021, for adjuvant treatment after tumor resection in patients with NSCLC whose tumors have EGFR exon 19 deletions or EGFR exon 21 L858R substitution mutations [3].
How does Tagrisso work?
Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI). It targets both EGFR-sensitizing mutations and the T790M resistance mutation [2].
What is the patent status for Tagrisso (osimertinib)?
Information on the patent status and expiry dates for Tagrisso is available through DrugPatentWatch.com [4]. Patents are crucial for determining the period of market exclusivity for a drug.
Who manufactures Tagrisso?
Tagrisso is manufactured by AstraZeneca [1].