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Guilford gets partial support for new Gliadel use (Reuters Securities) Guilford Pharmaceuticals Inc.(NasdaqNM: GLFD - news ) received partial support on Thursday from a U.S. advisory panel for the company`s push to expand approved uses for its Gliadel Wafer to treat certain brain tumors. - Dec 06 7:09 PM ET


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://biz.yahoo.com/rf/011206/n06366365_1.html

Posted on: 12/07/2001

Guilford gets partial support for new Gliadel use

By Lisa Richwine

SILVER SPRING, Md., Dec 6 (Reuters) - Guilford Pharmaceuticals Inc.(NasdaqNM:GLFD - news) received partial support on Thursday from a U.S. advisory panel for the company's push to expand approved uses for its Gliadel Wafer to treat certain brain tumors.

The product, a dime-sized wafer implanted in the brain to release chemotherapy, currently has U.S. clearance for prolonging survival in patients with recurrences of glioblastoma multiforme, a common type of brain cancer.

The company, based in Baltimore, wants Food and Drug Administration approval for using the wafer as initial treatment following surgery for a broader range of tumors known as malignant gliomas. Gliadel is the company's only marketed product.

The panel voted 8-5 that the product provided benefits with acceptable safety risks for that use. But earlier, the committee had voted 7-6 that the trial the company presented to prove its case was not adequate.

FDA official Robert Temple said he viewed the votes as a mixed message. He said officials would have to weigh the members' various comments before deciding whether to approve the new use.

"The panel was closely divided and had different views. Any split vote means you have to go back and think about it," Temple said in an interview.

David Wright, a Guilford executive vice president, said he felt the majority of panel members favored using the product for patients included in the expanded indication.

"They seemed to say the product appears to provide an extended benefit to those patients with this awful disease," Wright said in an interview.

The FDA approved the Gliadel Wafer in 1996. Surgeons place up to eight wafers into the cavity created when a tumor is removed. The wafers slowly dissolve over two to three weeks, sending high concentrations of the chemotherapy drug carmustine directly to the tumor site. The approach is designed to minimize drug exposure to other areas of the body, where the high doses needed would cause side effects.

Debate centered on whether the company's trial was statistically strong enough to show the wafer provided a meaningful benefit for implanting in patients at the time of their first brain surgery. Guilford officials argued that the wafer extended average survival from 11.6 months to 13.9 months.

"It's very compelling and it's consistent," said Dr. Scott Lippman, a panel member from The University of Texas M.D. Anderson Cancer Center.

Other panelists said the studies did not include enough patients to draw a firm conclusion.

"The strength of evidence is kind of borderline, not strong," said Dr. Stephen George, a statistician from Duke University Medical Center.

In the United States, about 8,000 to 12,000 surgeries are performed each year to treat malignant brain tumors. About one-third of patients have a recurrence after a first tumor is removed.

Trading in Guilford shares was halted during the panel meeting.



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