FDA Approves Wider Use of Guilford's Brain-Cancer Wafer
By Terence Chea
Washington Post Staff Writer
Friday, December 7, 2001; Page E05
Guilford Pharmaceuticals Inc. of Baltimore gained limited support from a federal panel yesterday to expand the market for its implantable brain-cancer treatment drug.
The Food and Drug Administration's advisory committee on oncological drugs voted 8 to 5 to endorse the use of the Gliadel wafer to treat patients newly diagnosed with malignant glioma, a form of brain cancer. Gliadel is currently approved for use only when brain tumors grow back after initial surgery. Some panelists, however, voiced concerns about Gliadel's benefits and the patient study's design.
The FDA will make the final decision on whether to approve Gliadel's label expansion, but advisory panels' recommendations usually play an important role in the agency's decisions. The panel's lukewarm endorsement is likely to make the FDA's decision more difficult.
Guilford has several experimental drugs in patient testing, but Gliadel is the company's only approved product. The company's stock fell swiftly during the summer after it announced disappointing test results for its drug for Parkinson's disease. In the three months ended Sept. 30, the wafer generated $5.9 million in sales, almost all of the company's quarterly revenue.
David Wright, Guilford's executive vice president of commercial operations, said FDA approval would increase the potential market from about 4,000 patients today to between 8,000 and 10,000 patients. He said a decision could come within 90 days.
The Gliadel wafer is a dime-size, biodegradeable disk that is inserted through surgery and delivers chemotherapy directly onto the site of brain tumors. In September 1996, the FDA approved Gliadel as a supplemental treatment to surgery.
In June 2000, Guilford completed an advanced patient trial of Gliadel to study its effects at the time of initial diagnosis and surgery. The trial, which involved 240 men and women, found that Gliadel patients lived about three months longer than patients receiving a placebo, company officials said.
The decision was announced after the stock market's close. Guilford shares rose 81 cents, or 7 percent, yesterday to close at $12.75 on the Nasdaq Stock Market, far below its 52-week high of $35.99. |
