Gliadel Wafer has been approved as the first brain cancer treatment to deliver chemotherapy directly to the tumor site. The product was cleared by the FDA for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme (GBM) for whom surgical resection is indicated.
Gliadel Wafer, a new approach to the treatment of recurrent GBM, is a biodegradable wafer implanted at the time of surgery that delivers chemotherapy directly to the tumor site minimizing drug exposure to other areas of the body. Gliadel Wafer complements other standard therapies for brain cancer, such as surgery, radiation and traditional intravenous chemotherapy.
In September 1996, Gliadel Wafer was cleared for marketing based on data from a landmark study involving 222 patients undergoing surgery for recurrent malignant glioma. Results from this Phase III double-blind, placebo-controlled clinical study showed that Gliadel Wafer increased survival at six months by more than 50 percent (from 36% with placebo to 56% with Gliadel Wafer) in patients with GBM.
The spectrum of adverse events observed in patients who received Gliadel Wafer was consistent with that encountered in patients undergoing surgery for malignant gliomas. The incidence of seizures was the same in the placebo and Gliadel Wafer groups, however, patients receiving Gliadel had an earlier onset of seizures. In Phase III studies, side effects that were more common with Gliadel Wafer versus placebo included pain and healing abnormalities. Other side effects that were more common than seen with placebo, but not statistically significant, were brain edema and local infections.
GBM is one of the most rapidly progressive and universally fatal of all cancers. There are approximately 20,000 primary brain tumors diagnosed in the United States each year and GBM is the most common type.