Bayer’s cancer brand Stivarga (regorafenib) has been approved in the European Union to treat gastrointestinal stromal tumours (GIST) which cannot be removed or which have spread.
Patients must have progressed on – or must be intolerant to – prior treatment with Novartis’ Glivec (imatinib) and Pfizer’s Sutent (sunitinib) and the European Commission decision is based on the phase III GRID trial in which Stivarga extended progression-free survival (PFS) over five times more than placebo.
The decision follows similar approvals in the US and Japan, and is the second indication – after metastatic colorectal cancer (mCRC) – for which the oral multi-kinase inhibitor has been given the green light in Europe in a year.
Joerg Moeller, head of global development at Bayer, said: “We are delighted to offer patients in Europe a new option for treating this rare yet relentless cancer.”
GISTs are found in the digestive system, most commonly in the stomach. Many of these tumours are benign and cause few symptoms. If they become malignant and are confined to one area of the stomach or bowel, they can often be removed surgically – but this is not always the case.
GRID showed that Stivarga plus best supportive care reduced the risk of progression or death by 73 per cent compared to placebo: median PFS was 4.8 months versus 0.9 months.
Full results from the study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June 2012 and published in November the same year in The Lancet.
GRID investigator Jean Yves-Blay said: “GIST is a highly aggressive cancer that can go undetected for years and, at the point of diagnosis, most patients have already progressed to advanced stages of disease. Survival rates are low and treatments are limited after imatinib and sunitinib.”
The most serious adverse drug reactions were hepatotoxicity, haemorrhage and gastrointestinal perforation, and these generally occur within the first two treatment cycles, making close monitoring of patients important.