A Baltimore biotechnology company yesterday won the next-to-last federal approval needed to commercialize its cancer-fighting brain implant, and Guilford Pharmaceuticals Inc. said it will press for final approval early next year.
Guilford said the Food and Drug Administration approved a "treatment investigational new drug" application for the
company's Gliadel brain implant. The product is a wafer saturated with chemotherapy drugs that surgeons implant in the cavity left in a patient's brain upon removal of a malignant tumor.
The premise is that the implant will prevent relapses -- and will reduce the much-feared side effects of chemotherapy -- by applying drugs directly to any cancer cells left behind after surgery. Conventional therapy forces the drugs to course through a patient's bloodstream before reaching cancerous cells, which is toxic to otherwise healthy parts of the body.
About 20,000 operations to remove malignant brain tumors are performed annually in the United States.
A treatment IND allows Guilford to make the product available to neurosurgeons, but limits the amount the company can charge for the treatment and sharply limits the ways Gliadel can be promoted, Guilford chief executive Craig Smith said.
The next step is to file a new drug application, approval of which would allow Guilford to sell the implants commercially. Dr. Smith said the company had planned to file the application this year, but will delay it slightly to include the results of a new clinical trial of Gliadel conducted in Europe.
"We've told people we expect the results to be positive, but we're not telling them any more than that," Dr. Smith said. "We have a responsibility to have these data presented in a scientific forum before they're presented in a nonscientific forum."
The company has already built a factory in Baltimore to manufacture Gliadel.