Tagrisso | MedDataX

Drug Profile

Tagrisso is the brand name for osimertinib, a kinase inhibitor used in EGFR mutation-positive non-small cell lung cancer across adjuvant, unresectable stage III, first-line metastatic/locally advanced, and previously treated T790M-positive metastatic settings. U.S. labeling shows initial approval in 2015 with major indication updates through September 2024.

Drug Class: Kinase inhibitor (EGFR-targeted)
Approval Status: FDA approved (Initial U.S. Approval: 2015; major label updates through September 2024)
Mechanism of Action: EGFR-targeted kinase inhibition used for tumors with EGFR exon 19 deletion, exon 21 L858R, and T790M mutation contexts.

Brand Names

TAGRISSO

Indications

\Adjuvant therapy after tumor resection for adult NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation\
\Treatment of adult locally advanced unresectable stage III NSCLC without progression after platinum-based chemoradiation and with EGFR exon 19 deletion or exon 21 L858R mutation\
\First-line treatment of adult metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation\
\First-line combination with pemetrexed and platinum-based chemotherapy for locally advanced or metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R mutation\
\Treatment of adult metastatic EGFR T790M mutation-positive NSCLC after progression on EGFR TKI therapy\

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Related Clinical Trials

NCT ID	Title	Status	Phase
NCT06306456	A Phase Ib/II Clinical Study of GH21 Capsules Combined With Osimertinib Mesylate Tablets in Patients With NSCLC	RECRUITING	PHASE1/PHASE2
NCT03969823	Whole Genomic Landscape of Advanced EGFR-mutant NSCLC	ACTIVE_NOT_RECRUITING	NA
NCT02824952	Neo-adjuvant Trial With AZD9291 in EGFRm+ Stage IIIA/B NSCLC	UNKNOWN	PHASE2