TAGRISSO® – the first and only EGFR TKI to extend survival in patients with EGFRm NSCLC.1,2
TAGRISSO® (osimertinib) as monotherapy is indicated for:3
- 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 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:3
- 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.
References:
- Tsuboi M, et al., Overall Survival with Osimertinib in Resected EGFR-Mutated NSCLC. N Engl J Med. 2023. 389:137–47. doi: 10.1056/NEJMoa2304594.
- Ramalingam SS, et al. Overall Survival with Osimertinib in Untreated, EGFR-Mutated Advanced NSCLC; N Engl J Med. 2020; 382:41-50.
- TAGRISSO® Information for Healthcare Professionals, www.swissmedicinfo.ch
TAGRISSO®
Comp: Osimertinib; 40 mg and 80 mg film-coated tablets; List A. Ind: TAGRISSO is indicated as monotherapy for the adjuvant treatment after complete tumour resection in adult patients with non-squamous, non-small cell lung cancer (NSCLC) with EGFR (epidermal growth factor receptor) exon 19 deletions or exon 21 (L858R) substitution mutations, for the first-line treatment in adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR‑T790M‑mutation who have progressed on or after EGFR TKI therapy, as well as in combination with 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. Dos: 80 mg once daily in monotherapy as well as in combination with pemetrexed and 4 cycles platinum-based chemotherapy. CI: Hypersensitivity to the active substance or to any of the excipients. Concomitant use of St. John’s Wort. W&P: Interstitial lung disease. Erythema multiforme. QTc interval prolongation. LVEF and cardiomyopathy. Diarrhoea. Age and body weight. IA: Strong CYP3A inducers. CYP3A4 substrates and transporters. ADRs: Very common: diarrhoea, stomatitis, rash, dry skin, paronychia, pruritus, platelet count decreased, leukocytes decreased, lymphocytes decreased, neutrophils decreased, blood creatinine increased. Common: interstitial lung disease, epistaxis, palmar-plantar erythrodysaesthesia syndrome, alopecia, urticaria, blood creatine phosphokinase increased, QTc interval prolongation, cardiac failure, left ventricular ejection fraction decreased, erythema multiforme, skin hyperpigmentation. Uncommon, rare, very rare: see www.swissmedicinfo.ch. Date of revision of the text: December 2023.
Further information: www.swissmedicinfo.ch or AstraZeneca AG, Neuhofstrasse 34, 6340 Baar, Switzerland. www.astrazeneca.ch.
Professionals can request the mentioned references from AstraZeneca AG.