FDA nod is sought for cancer drug

September 29, 1995|By Timothy J. Mullaney | Timothy J. Mullaney,SUN STAFF

Guilford Pharmaceuticals Inc. of Baltimore said yesterday that it has asked the U.S. Food and Drug Administration for limited marketing approval for its Gliadel cancer drug implant, which is designed to fight relapses of brain cancer.

The company said it filed an investigational new drug application, which, if approved, would allow the 2-year old firm to give Gliadel to a limited number of patients outside the setting of an organized clinical trial while Guilford pursues full FDA marketing approval.

Guilford President Craig Smith said the company plans to ask for full marketing approval by the end of this year, after the company has the results of a European clinical trial and has the results of an FDA inspection of its Baltimore plant that is part of the investigational drug application process.

Gliadel is a wafer saturated with chemotherapy drugs that surgeons implant after removing brain tumors. As the wafer dissolves, it releases the drugs in a way that delivers treatment more directly than conventional chemotherapy to the diseased cells remaining after surgery, allowing Gliadel to reduce chemotherapy-related side effects while using the same chemical agents.

Security analysts contend that Guilford will sell up to $75 million worth of Gliadel annually by 1998.

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