30 October 2013
A recently approved drug for lung cancer has moved closer to being used in the clinic in the UK after new research provided the latest confirmation of its safety.
Researchers at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust found that afatinib did not affect cardiac function, and had no unexpected side-effects.
Afatinib, a drug targeting the epidermal growth factor receptor (EGFR), was granted marketing authorisation by the European Commission in September 2013 as a first-line treatment over chemotherapy for non-small cell lung cancer patients with activating EGFR mutations.
Several studies have previously found that afatinib is generally safe and well tolerated, but researchers wanted to investigate its effect on cardiac repolarisation, or how long the heart takes to prepare for the next contraction.
The new findings, reported in the journal Cancer Chemotherapy and Pharmacology, are reassuring, as some drugs similar to afatinib have shown evidence of affecting this aspect of cardiac function in patients.
The study researchers administered afatinib to 60 patients with relapsed or treatment-resistant solid tumours.
Study leader Dr Rhoda Molife, Medical Oncologist and Senior Investigator in Phase I Clinical Studies at The Institute of Cancer Research and The Royal Marsden Hospital, said:
“Previous and ongoing studies have previously demonstrated the manageable safety profile of afatinib. However, this particular trial was specifically designed to investigate the cardiac effects of the drug and in particular cardiac repolarisation. Most drugs submitted for approval must undergo this rigorous cardiac testing even after pre-clinical assessments.
"The fact that this study was able to show a clean cardiac safety profile adds important information to the safety profile of the drug and may hopefully contribute to paving the way for clinical use in lung cancer patients in the UK.”