Our targeted oncology drug Erbitux® (cetuximab) is approved in combination with chemotherapy 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.
Approvals in Japan, Australia and Switzerland
In Japan, Erbitux® can now be used in combination with chemotherapy in the first-line treatment 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.
Erbitux® is the standard of care in KRAS wild-type metastatic colorectal cancer
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 mCRC. The share of patients in whom the test is performed in order to determine whether they can benefit from a personalized therapy, such as Erbitux®, increased from 2.5% in 2008 to 66% in early 2010. The results also show that 73% of physicians in Europe already routinely tested KRAS status at diagnosis of metastatic colorectal cancer. Data from two surveys, which were likewise presented in 2010, show that Erbitux® has become a standard of care in the treatment of both locally advanced and recurrent and/or metastatic SCCHN. The results from the survey of 256 specialists in France, Germany, Italy and Spain in the latter indication showed that an Erbitux®-based treatment combination was used in almost 60% of cases in the first-line setting.