Tagrisso FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 21, 2024.
FDA Approved: Yes (First approved November 13, 2015)
Brand name: Tagrisso
Generic name: osimertinib
Dosage form: Tablets
Company: AstraZeneca
Treatment for: Non-Small Cell Lung Cancer
Tagrisso (osimertinib) is a tyrosine kinase inhibitor used for the treatment of epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
- Tagrisso is indicated for:
- adjuvant therapy after tumor resection in adult patients with non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test .
- the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
- in combination with pemetrexed and platinum-based chemotherapy, the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.
- the treatment of adult patients with metastatic EGFR T790M mutationpositive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy. - Tagrisso tablets are taken orally once daily, with or without food.
- Warnings and preacautions include QTc interval prolongation; cardiomyopathy; keratitis; erythema multiforme major, Stevens-Johnson syndrome, and toxic epidermal necrolysis; cutaneous vasculitis; aplastic anemia; and embryo-fetal toxicity.
- Common adverse reactions of Tagrisso monotherapy include leukopenia, lymphopenia, thrombocytopenia, anemia, diarrhea, rash, musculoskeletal pain, neutropenia, nail toxicity, dry skin, stomatitis, and fatigue.
Common adverse reactions of Tagrisso in in combination with pemetrexed and platinum-based chemotherapy include leukopenia, thrombocytopenia, neutropenia, lymphopenia, rash, diarrhea, stomatitis, nail toxicity, dry skin, and increased blood creatinine.
Development timeline for Tagrisso
Further information
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