TAGRISSO® (osimertinib) as monotherapy is indicated for:1
- the adjuvant treatment after complete tumour resection in adult patients with non-squamous, non small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations.
- the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following definitive platinum‑based chemoradiation therapy.
- the first-line treatment of adult patients with locally advanced or metastatic NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
- the treatment of adult patients with locally advanced or metastatic EGFR-T790M-mutation-positive NSCLC who have progressed on or after EGFR TKI therapy.
TAGRISSO® (osimertinib) is indicated in combination with:1
- pemetrexed and platinum-based chemotherapy for the first-line treatment of adult patients with locally advanced or metastatic, non-squamous NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations.
TAGRISSO® Product Information
For more information, please consult the TAGRISSO® Product Information (PI) in German, in French or in Italian or contact AstraZeneca AG, Neuhofstrasse 34, 6340 Baar, Switzerland. www.astrazeneca.ch
1G TKI: first generation tyrosine kinase inhibitor; CI: confidence interval; CRT: chemoradiotherapy; EGFRm: epidermal growth factor receptor mutation; HR: hazard ratio; mOS: median overall survival; NSCLC: non-small cell lung cancer; OS: overall survival; SL: list of specialities.
References:
- TAGRISSO® Information for Healthcare Professionals, www.swissmedicinfo.ch.
- Tsuboi M, Herbst RS, John T, et al; ADAURA Investigators. Overall survival with osimertinib in resected EGFR-mutated NSCLC. N Engl J Med. 2023;389(2):137-147.
- Ramalingam SS, et al. LBA4: Osimertinib (osi) after definitive chemoradiotherapy (CRT) in patients (pts) with unresectable (UR) stage III EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC): Updated overall survival (OS) analysis from the LAURA study. Presented at: European Lung Cancer Congress (ELCC) 2025, March 26-29, 2025; Paris, France.
- Ramalingam SS, et al; FLAURA Investigators. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC. N Engl J Med. 2020 Jan 2;382(1):41-50.
- Jänne PA, et al. Survival with Osimertinib plus Chemotherapy in EGFRm advanced NSCLC. NEngl J Med. 2025; DOI:10.1056/NEJMoa2510308.
- Herbst RS, et al. Adjuvant Osimertinib for Resected EGFR-Mutated Stage IB-IIIA Non-Small-Cell Lung Cancer: Updated Results From the Phase III Randomized ADAURA Trial. J Clin Oncol. 2023 Apr 1;41(10):1830-1840.
- Lu S, et al. Osimertinib after Chemoradiotherapy in Stage III EGFR-Mutated NSCLC. N Engl J Med. 2024;391(7):585-597.
- Planchard D, et al. Osimertinib with or without chemotherapy in EGFR-mutated advanced NSCLC. N Engl J Med. 2023;389(21):1935-1948.
- Individualized patient care: Depending on individual patient characteristics and preferences, TAGRISSO® is the only EGFR TKI that is approved to be taken alone or in combination with pemetrexed and platinum-based chemotherapy for the 1L treatment of locally advanced or metastatic NSCLC to maximize either for tolerability or efficacy.1
- Unmatched efficacy: TAGRISSO® is the only targeted treatment that has shown in phase III trials a median DFS of 65.8 months in fully resected EGFRm NSCLC6, and a median PFS of 39.1 months in unresectable EGFRm NSCLC following CRT7 when given alone, as well as a median PFS of 29.4 months (BICR) in 1L locally advanced and metastatic NSCLC when given with chemotherapy8.
- Across all stages: TAGRISSO® is approved for patients with resectable, unresectable, as well as locally advanced and metastatic EGFRm NSCLC.1
- +EGFRm = Exon 19 deletions or exon 21 (L858R) substitution mutations
- #non-squamous NSCLC.
Professionals can request the mentioned references from AstraZeneca AG.
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