A new indication for Bristol-Myers Squibb and Eli Lilly's Erbitux, sold outside the USA by Merck KGaA, has been approved by regulators across the Atlantic, as has a genetic test made by Qiagen, which may expand use of the colorectal cancer drug.
Erbitux (cetuximab) in combination with the FOLFIRI (infusional 5FU and irinotecan) chemotherapy regimen has been granted full approval by the US Food and Drug Administration for the first-line treatment of patients with KRAS mutation-negative (KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer. The expanded thumbs-up in the latter (Erbitux is also approved for head and neck cancer) is based on data from the CRYSTAL Phase III study conducted by Merck in Europe which showed a significant overall survival advantage for patients who were treated with Erbitux in combination with FOLFIRI compared to those who received chemotherapy alone; 8.9 versus 8.1 months.
The latest green light is tied to the agency's approval of Qiagen's diagnostic kit which can provide information about the KRAS gene mutation. Some 110,000 colorectal cancer patients each year in the USA could benefit from testing, says Qiagen, noting that "the presence or absence of KRAS mutations in tumours affects outcomes". Approximately 60% of patients with wild-type KRAS genes may benefit from anti-EGFR therapy, while 40% whose tumours have KRAS mutations may not.
Qiagen went on to say that the healthcare system across the pond could save more than $600 million annually "by avoiding unnecessary use of medicines in colorectal cancer patients through determinations of their KRAS status". Brian Daniels, head of global development and medical affairs at B-MS, added that "cancer is a heterogeneous disease and we have learned that not all patients with mCRC should be viewed as the same".
Until now, doctors have been using tests not approved by the FDA to determine KRAS status. Qiagen's kit is the first to get the agency's green light and sales of the KRAS test in colon cancer alone are expected to be to be about $20 million annually.
The approvals come days after a late-stage clinical trial of Erbitux in advanced stomach tumours failed to show a significant benefit in progression-free survival.