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Genetic testing could spur Erbitux drug sales

June 1, 2010

Genetic screening to predict which bowel cancer patients will benefit from Eli Lilly and Co.'s tumor- fighting drug Erbitux is becoming more common, according to the Indianapolis-based company's overseas partner, Merck KGaA, while citing a survey that may point to broader use of the treatment.

At least 42 percent of metastatic colorectal cancer patients had been tested early last year for a gene that can predict whether Erbitux will help them, said Oliver Kisker, Merck’s head of cancer clinical development. Testing rates reached 60 percent by the end of 2009, Kisker told German magazine Wirtschaftswoche this month. Screening rates rose further this year, he said Monday, while declining to confirm the Wirtschaftswoche report.

Merck is counting on screening for the so-called K-ras gene to spur use of Erbitux in metastatic colorectal cancer after European regulators refused to widen approval of the drug to lung cancer patients last year. Research has shown the medicine is more likely to be effective in colorectal cancer patients without a mutated version of the gene. Use of the test spread from 2.5 percent of patients in 2008, the Merck survey found.

“This is amazing,” Kisker said in a telephone interview. The increase is “a very important indicator to us that this treatment now becomes, at least for many areas, part of the standard treatment.”

The survey results through early last year will be presented Tuesday at the American Society of Clinical Oncology meeting in Chicago. Results through early 2010 will be presented at the World Congress on Gastrointestinal Cancer in June, Kisker said.

Erbitux competes with Roche Holding AG’s Avastin and with Amgen Inc.’s Vectibix. Of the 42 percent of patients tested for K-ras in early 2009, 44 percent were treated with the Lilly drug, according to the survey. Almost a quarter of physicians use the genetic screening as a standard part of the diagnostic procedure for metastatic colorectal cancer, Merck said.

The company surveyed 1,254 physicians in Asia, Europe and Latin America. Merck, which isn’t related to U.S. drugmaker Merck & Co., sells Erbitux outside the U.S. and Canada. Lilly and Bristol-Myers Squibb Co. market the medicine in the U.S.

Merck reported $856 million in Erbitux sales last year. The drugmaker’s oncology program suffered twin setbacks in the past 12 months, as European regulators rejected Erbitux in lung cancer and U.S. regulators placed trials of its therapeutic cancer vaccine Stimuvax on hold in March after a patient developed a brain infection while taking it.

Merck remains in talks with the Food and Drug Administration about the halted Stimuvax trials, Kisker said. He declined to say when the discussions would finish or what kind of information the regulator requested.

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