Bristol-Myers Squibb Co. (BMY:US) and Eli Lilly & Co. (LLY:US) won U.S. regulatory approval to expand the use of Erbitux as an initial treatment against colorectal cancer that has spread for patients who are first given a genetic screening.
Erbitux should be taken only by patients who have used an agency-approved test to predict whether the drug will work, according to the medicine’s label posted on the Food and Drug Administration’s website. The agency also cleared the threascreen test made by Venlo, Netherlands-based Qiagen NV (QGEN:US), the first FDA-approved diagnostic that will evaluate each patient’s likelihood of responding to the cancer treatment, Michelle Bolek, a spokeswoman for the agency, said in an e-mail.
Erbitux also is an initial treatment for head and neck cancer and was previously approved to treat patients with colorectal cancer that has spread and who have tried other drugs. The Qiagen test is intended to weed out the 40 percent of colorectal cancer patients who have a Kras gene mutation that makes them unresponsive to Erbitux, according to the company. The approvals are at least the third time in the past year the agency has backed a cancer drug and an accompanying genetic test to better target the most appropriate patients.
“We are proud to be helping to make health care more effective, providing ways for payers to more efficiently use health-care resources and, most important, making a positive impact on the care of patients,” Qiagen Chief Executive Officer Peer Schatz said today in a statement.
While there are tests available that don’t require FDA approval, Qiagen sought clearance because such government validation benefits the product’s market potential, Schatz said in an April earnings call. The market potential for the test is $20 million.
“FDA is clearly making signals that they want to see more FDA-approved products and reimbursement is also going in that direction,” Schatz said. “So all of these things together make us feel quite good.”
Erbitux generated $691 million in sales (BMY:US) for New York-based Bristol-Myers last year, according to data compiled by Bloomberg. The expanded use of the drug for colorectal cancer isn’t expected to add much in terms of sales, Les Funtleyder, a fund manager at the hedge fund Poliwogg in New York, said.
“It’s always a positive but it very rarely amounts to anything dramatic in terms of revenue, especially for a drug that’s been on the market a long time like Erbitux,” Funtleyder said. Merck KGaA sells Erbitux outside the U.S.
Cancer of the colon or rectum is the fourth-most common cancer in men and women, according to the National Institutes of Health. More than 143,000 people will be diagnosed with the disease this year.
Qiagen has more than 15 projects under way to co-develop and market companion diagnostics with drugmakers including Amgen Inc. (AMGN:US), based in Thousand Oaks, California, Indianapolis-based Lilly and New York-based Pfizer (PFE:US) Inc., according to the company.
“It’s not a one-off,” Stephen Little, vice president of personalized medicine at Qiagen, said in a telephone interview. “It’s part of a much bigger trend in medicine.”
The next companion diagnostic Qiagen will introduce probably will be with Boehringer Ingelheim GmbH for a lung cancer treatment, Little said.
The FDA convened a meeting on the oversight of diagnostic tests made by laboratories ranging from Madison, New Jersey- based Quest Diagnostics Inc. (DGX:US) to small individual operations. The agency generally hasn’t regulated tests that tended to be low risk and were developed and performed in labs.
The FDA said more complex tests are playing an increasing role in patient care, leading regulators to determine they may need to review some tests before they are on the market. Labs make many of the tests for the Kras gene mutation in use now.
“It’s appropriate to be sure these tests work well and understand what the information means and we’re really behind the regulators here,” Little said.
Qiagen tested its diagnostic during the final phase of clinical trials on Erbitux for the expanded use in colorectal cancer, he said.
About 10 percent of marketed drugs recommend genetic testing for optimal treatment, according to the Washington-based Personalized Medicine Coalition, whose members include drugmakers, diagnostic companies, patient advocacy groups and research institutions.
The FDA approved Roche Holding AG (ROG)’s Zelboraf for a life- threatening form of skin cancer and Pfizer’s Xalkori to treat a rare form of lung cancer both in August with a test to detect a gene mutation to determine whether patients will respond to the drugs.
An unapproved test “undermines the approval process that has been established to protect patients, fails to ensure that physicians have accurate information on which to make treatment decisions, and decreases the chances that physicians will adopt a new therapeutic-diagnostic approach,” FDA Commissioner Margaret Hamburg and National Institutes of Health Director Francis Collins wrote in a July 2010 article in the New England Journal of Medicine.
Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, told senators during a November hearing that guidelines for FDA oversight of lab-developed diagnostic tests were under administrative review by the Office of Management and Budget. The guidelines are still under administrative review, said Bolek, the FDA spokeswoman.
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