About IRESSA

There is a difference between surviving and living, and patient tolerability goals must be considered alongside efficacy goals. The following aspects were taken into account during the development of IRESSA (gefitinib):

  • Keeping patients active
  • Improving symptoms
  • Reducing the treatment burden
  • Having manageable side effects
  • Improving the ease of use for patients

IRESSA is a highly convenient once‐daily 250 mg oral medication that, unlike other first and second generation (erlotinib and afatinib) epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), can be taken with or without food at any time of day.1,2 It can be dissolved in water for patients who have difficulty swallowing, there are no storage requirements, and the dosing is standardised, regardless of weight, age, height, sex, ethnicity, and renal or hepatic function.3

Iressa Food Image

Adapted from IRESSA EU Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001016/WC500036358.pdf. Accessed 03 July 2017.

IRESSA targets and blocks the activity of the epidermal growth factor receptor tyrosine kinase (EGFR‐TK), an enzyme that regulates intracellular signalling pathways implicated in cancer cell proliferation and survival. Growth factor signalling has been identified as a key driver of tumour growth and spread in a wide range of cancers.

IRESSA is designed to specifically target the tumour with no need to use maximum tolerated dose.4,5

Studies have shown that tumours with an EGFR mutation are particularly sensitive to IRESSA.6,7 EGFR mutations are present in the tumours of approximately 30–41% of Asian and 10–17% of Western patients with NSCLC.8-15 In Japan in 2002, IRESSA was the first EGFR‐TK inhibitor (EGFR‐TKI) to be approved for use in lung cancer.

Today, IRESSA is a standard of care treatment across multiple countries around the globe for adults with locally advanced or metastatic NSCLC with activating mutations of EGFR‐TK.* Based on the results of a Phase IV study, IFUM,16 the label was updated in 2014, making IRESSA the first EGFR‐TKI to have an EU label allowing the use of circulating tumour DNA obtained from a blood sample to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.3

*Prescribers should check their local regulatory agency and AstraZeneca company for local indication information.

Safety and side effects

Compared with platinum‐based doublet chemotherapy, IRESSA is generally well tolerated, with the most common adverse events being mild‐to‐moderate skin rash and diarrhoea (Common Terminology Criteria for Adverse Events grade 1 or 2).6,17,18 It is not typically associated with the cytotoxic side‐effects commonly seen with chemotherapy.19

Further information on IRESSA’s safety profile is available on the "IPASS study" page.

For more detailed information about safety, please see the IRESSA EU Summary of Product Characteristics.

Iressa packshot

References

  1. Tarceva EU Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000618/WC500033994.pdf. Accessed 03 July 2017.
  2. Giotrif EU Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002280/WC500152392.pdf. Accessed 03 July 2017.
  3. IRESSA EU Summary of Product Characteristics. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/001016/WC500036358.pdf. Accessed 03 July 2017.
  4. Wolf M et al. Development of the novel biologically targeted anticancer agent gefitinib: determining the optimum dose for clinical efficacy. Clin Cancer Res 2004; 10: 4607–4613
  5. Rukazenkov Y et al. Epidermal growth factor receptor tyrosine kinase inhibitors: similar but different? Anticancer Drugs 2009; 20: 856–866.
  6. Mok TS et al. Gefitinib or carboplatin–paclitaxel in pulmonary adenocarcinoma. N Engl J Med 2009; 361: 947–957.
  7. Sequist LV et al. First-line gefitinib in patients with advanced non-small cell lung cancer harbouring somatic EGFR mutations. J Clin Oncol 2008; 26: 2442–2449.
  8. Shigematsu H et al. Clinical and biological features associated with epidermal growth factor receptor gene mutations in lung cancers. J Natl Cancer Inst 2005; 97: 339–346.
  9. Yang SH et al. Mutations in the tyrosine kinase domain of the epidermal growth factor receptor in non-small cell lung cancer. Clin Cancer Res 2005; 11: 2106–2110.
  10. Rosell R et al. Screening for epidermal growth factor receptor mutations in lung cancer. N Engl J Med 2009; 361: 958–967.
  11. Rosell R et al. Erlotinib versus standard chemotherapy as first-line treatment for European patients with advanced EGFR mutation-positive non-small-cell lung cancer (EURTAC): a multicentre, open-label, randomised Phase 3 trial. Lancet Oncol 2012; 13: 239–246.
  12. Douillard J-Y et al. First-line gefitinib in Caucasian EGFR mutation-positive NSCLC patients: a Phase-IV, open-label, single-arm study. Br J Cancer 2014; 110: 55–62.
  13. Han B et al. Determining the prevalence of EGFR mutations in Asian and Russian patients (pts) with advanced non-small-cell lung cancer (aNSCLC) of adenocarcinoma (ADC) and non-ADC histology: IGNITE study. Annals of Oncol 2015; 26(suppl 1): i29–i44.
  14. Reck M et al. Investigating the utility of circulating-free tumour-derived DNA (ctDNA) in plasma for the detection of epidermal growth factor receptor (EGFR) mutation status in European and Japanese patients (pts) with advanced non-small-cell lung cancer (aNSCLC): ASSESS study. Annals of Oncol 2015; 26(suppl 1): i57–i61.
  15. Schuette W et al. EGFR Mutation Status and First-line Treatment in Patients with Stage III/IV Non-small cell Lung Cancer in Germany: An Observational Study. Cancer Epidemiol Biomarkers Prev 2015 [Epub ahead of print].
  16. Douillard J-Y et al. Gefitinib treatment in EGFR mutated Caucasian NSCLC. Circulating-free tumour DNA as a surrogate for determination of EGFR status. J Thorac Oncol 2014; 9: 1345–1353.
  17. Maemondo M et al. Gefitinib or chemotherapy for non-small-cell lung cancer with mutated EGFR. N Engl J Med 2010; 362: 2380–2388.
  18. Mitsudomi T et al. Gefitinib versus cisplatin plus docetaxel in patients with non-small-cell lung cancer harbouring mutations of the epidermal growth factor receptor (WJTOG3405): an open label, randomised phase 3 trial. Lancet Oncol 2010; 11: 121–128.
  19. Forsythe B and Faulkner K. Overview of the tolerability of gefitinib (IRESSA) monotherapy: clinical experience in non-small-cell lung cancer. Drug Saf 2004; 27: 1081–1092