Merck Serono confirmed Japanese regulatory clearance for Erbitux® in combination with chemotherapy as a first-line treatment of EGFR-expressing, inoperable advanced, or recurrent KRAS wildtype colorectal cancer (mCRC).
The expanded approval was based on data from the Phase III CRYSTAL trial. Erbitux was previously sanctioned in Japan as a combination therapy with irinotecan in EGFR-expressing mCRC patients who had failed prior irinotecan therapy. Merck jointly develops and markets Erbitux in Japan with ImClone and Bristol-Myers Squibb.
Merck reported Erbitux-related sales of €697 million (over $937 million) in 2009, up 23% on 2008. The drug is currently approved in the U.S., EU, and other countries as a combination therapy with irinotecan for EGFR-expressing mCRC in patients who have failed prior irinotecan therapy. A number of countries have also cleared the drug as a single-agent, according to the firm.
In 2006, the EU became the first region to approve Erbitux in combination with radiotherapy for the treatment of locally advanced squamous cell carcinoma of the head and neck (SCCHN). Other countries have approved Erbitux as a monotherapy in patients with recurrent and/or metastatic SCCHN who have failed prior chemotherapy.
In July 2008, EU clearance of Erbitux was expanded to include its use in EGFR-expressing, KRAS wild-type mCRC in combination with chemotherapy and as a single agent in patients who had faield oxaliplatin- and irinotecan-based therapy and those intolerant to irinotecan. Four months later the license was updated again in the EU to encompass the use of Erbitux in combination with platinum-based chemotherapy in patients with recurrent and/or metastatic SCCHN.
On the downside, in July 2009 the EMEA’s Committee for Medicinal Products for Human Use said that it would not recommend approval of Erbitux in combination with platinum-based chemotherapy in patients with EGFR-expressing advanced or metastatic non-small-cell lung cancer (NSCLC). Merck Serono has subsequently requested the committee to re-examine the Phase III data.
The firm maintains Erbitux represents the first and only new targeted compound in clinical development in more than 10 years that increases overall survival in a particular NSCLC patient population as well as all histologies.