Tagrisso FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 2, 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 treatment of adult patients with locally advanced, unresectable (stage III) NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy and whose tumors have 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 mutation-positive 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 interstitial lung disease (ILD)/pneumonitis; 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.
- of Tagrisso monotherapy following platinum-based chemoradiation therapy include lymphopenia, leukopenia, ILD/pneumonitis, thrombocytopenia, neutropenia, rash, diarrhea, nail toxicity, musculoskeletal pain, cough and COVID-19.
- of Tagrisso 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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