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):
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
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.
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.