Merck 2010 Annual Report Download - page 54

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Oncology
Neurodegenerative Diseases
Rheumatology
Fertility
Endocrinology
CardioMetabolic Care and General Medicine
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Our targeted oncology drug Erbitux ® (cetuximab) is approved in combination with chemo-
therapy for all lines of treatment or as a monotherapy for pretreated patients in epidermal
growth factor receptor (EGFR)-expressing, KRAS wild-type metastatic colorectal cancer (mCRC).
In addition, the monoclonal antibody is a first-line standard for recurrent and/or metastatic
squamous cell carcinoma of the head and neck (SCCHN) in combination with platinum-based
chemotherapy, as well as in combination with radiotherapy for locally advanced head and
neck cancer. Erbitux ® is currently approved for use in colorectal cancer in 86 countries and
in head and neck cancer in 82 countries around the world. We are exploring further indications
in additional studies. Sales of Erbitux ® continued on a growth course in 2010, increasing by
18% to EUR 820 million.
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In Japan, Erbitux ® can now be used in combination with chemotherapy in the first-line treat-
ment of patients with EGFR-expressing, inoperable, advanced or recurrent colorectal cancer
carrying the KRAS wild-type gene. The Japanese Pharmaceutical and Medical Devices Agency
(PMDA) granted approval of this extended usage for Erbitux ® in March 2010 following submission
of data from the Phase III CRYSTAL trial. Consequently, Erbitux ® is now available for use in
combination with chemotherapy for colorectal cancer in all lines of treatment in Japan.
In Australia, the Therapeutic Goods Administration (TGA) approved Erbitux ® in March 2010
as a first-line treatment in combination with chemotherapy for patients with KRAS wild-type
mCRC. In Switzerland, Erbitux ® was also approved in 2010 as a first-line treatment option
for metastatic colorectal cancer patients with KRAS wild-type tumors. Swissmedic, the Swiss
Agency for Therapeutic Products, granted the approval in September 2010.
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Merck is a leader in innovative, personalized cancer therapy. We are focused on research to
identify biomarkers that will help to select the patients who will benefit the most from a specific
drug – as is the case with Erbitux ® and the KRAS wild-type status of tumors in patients with
metastatic colorectal cancer. An international survey conducted in 2010 showed that KRAS
mutation analysis is fast becoming an integral part of the management of mCRC. The survey
revealed in addition that Erbitux ® is now a standard of care for confirmed KRAS wild-type
Erbitux ® in combination with
chemotherapy available in Japan
for colorectal cancer in all lines of
treatment
Merck Annual Report 2010 50