Colorectal cancer patients have a new treatment option available thanks to a recent approval by the US Food and Drug Administration, although the approval will benefit a narrow subset of patients.
The FDA has granted full approval for the use of Erbitux (cetuximab) in combination with the FOLFIRI (irinotecan, 5-fluorouracil, leucovorin) combination chemotherapy regimen for the induction or first-line treatment of KRAS mutation-negative (also known as KRAS wild-type), epidermal growth factor receptor (EGFR)-expressing metastatic colorectal cancer.
According to Eli Lilly and Brystol-Myers Squibb, which together make and co-market the drug, it is now the first and only approved therapy for such a narrow subset of metastatic colorectal cancer patients.
The drug remains unapproved for KRAS-mutation positive metastatic colorectal cancer.
The FDA granted its full approval thanks to data from the so-called CRYSTAL trial (Cetuximab combined with iRinotecan in first-line therapY for metaSTatic colorectAL cancer), a Phase III, open-label, randomized, multicenter trial condiucted outside the U.S. that used European Union (EU)-approved cetuximab as the clinical trial material. The primary end-point of the trial was progression-free survival.
Source: FDA
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