Bristol-Myers Squibb Company
) and partner
Eli Lilly & Company
) recently announced that they have received approval from the US
Food and Drug Administration (FDA) for a label expansion of their
cancer drug, Erbitux.
The companies gained approval for the use of Erbitux as a
first-line treatment in combination with FOLFIRI in patients with
wild-type KRAS, epidermal growth factor receptor (EGFR)-expressing
metastatic colorectal cancer (mCRC).
The FDA approved Erbitux for the new indication on the basis of
data from an open-label, randomized, multicenter phase III study
(CRYSTAL) conducted in ex-US markets. The clearance of the
combination therapy marks the first FDA approval in nearly a decade
for treating patients newly diagnosed with mCRC. Following the
FDA's decision, Erbitux becomes the first and only FDA-approved
drug for treating mCRC patients with wild-type KRAS. The FDA stated
that Erbitux should not be used to treat patients with KRAS
mutation-positive colorectal cancer.
The FDA also stated that Erbitux should only be used to treat those
mCRC patients who have undergone an FDA-approved test to foecast
whether the drug will work. Apart from approving the label
expansion, the FDA also cleared
) therascreen KRAS test kit which will serve as guidance on the use
of Erbitux for treating mCRC patients.
The label expansion of Erbitux, already approved for multiple
indications, should boost the sales potential of the cancer drug.
The colorectal cancer market represents huge potential. According
to estimates provided by the company in its press release, about
143,460 cases of colorectal cancer are expected to occur in 2012.
Apart from Erbitux, the colorectal cancer market includes
Neutral on Bristol-Myers, Eli Lilly
We currently have a Neutral recommendation on Bristol-Myers in the
long-run. The company carries a Zacks #3 Rank (Hold rating) in the
short-run. We have a similar stance on Eli Lilly.
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