US FDA Approves Erbitux for KRAS Wild-Type Cancer

A new indication for Bristol-Myers Squibb (BMS) and Eli Lilly’s Erbitux, which is sold outside the USA by Merck KGaA, has been approved by US regulators.

Meanwhile, the US Food and Drug Administration (FDA) have also cleared the first KRAS companion diagnostic test, the therascreen KRAS diagnostic kit which was developed by the Netherlands-based firm, Qiagen.

Erbitux (cetuximab) combined with the FOLFIRI (infusional 5FU and irinotecan) chemotherapy regimen has been granted full approval by the FDA 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 approval of the Erbitux for KRAS Wild-Type Cancer is based on data from the CRYSTAL Phase III clinical research study led by Merck in Europe which demonstrated a noteworthy overall survival advantage for patients who were treated with Erbitux and FOLFIRI in comparison to patients who only received chemotherapy.

The latest approval is linked to the FDA’s clearing of Qiagen’s  diagnostic kit which can provide information regarding the KRAS gene mutation. Approximately 110,000 colorectal cancer patients in the USA could benefit from testing each year, commented Qiagen, adding that “the presence or absence of KRAS mutations in tumours affects outcomes.”

Roughly 60% of patients with wild-type KRAS genes could benefit from anti-EGFR therapy, although 40% whose tumours have KRAS mutations may not.

Qiagen noted that the healthcare system could save over $600 million per year “by avoiding unnecessary use of medicines in colorectal cancer patients through determinations of their KRAS status.”

Senior vice president of Bristol-Myers Squibb’s Global Development and Medical Affairs department, Brian Daniels, added that “cancer is a heterogeneous disease and we have learned that not all patients with mCRC should be viewed as the same.”

“Today’s approval demonstrates our ability to bring diverse cancer therapies to market that address the needs of patients with KRAS mutation-negative (wild-type) mCRC,” he added.

Up until now, doctors had been using assessments not officially cleared by the regulatory agency to determine KRAS status.  Qiagen’s kit is the first to receive FDA clearing and sales of the KRAS test in colon cancer alone are projected to be around $20 million each year.

Following the approval, Erbitux has now become the first and only US Food and Drug Administration approved treatment for a specific subset of mCRC patients, targeting those with KRAS wild-type tumours.

Erbitux is, however, not indicated for the treatment of KRAS mutation-positive colorectal cancer.


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