First Launch Of Gliadel Implant For Brain Tumors

Rhone-Poulenc Rorer has launched its implantable brain tumor treatment,Gliadel Wafer (polifeprosan 20 with carmustine) in the USA, its first world market. The product was cleared in September 1996 for use as an adjunct to surgery to prolong survival in patients with recurrent glioblastoma multiforme, for whom surgical resection is indicated.

Gliadel was originally developed by Guilford Pharmaceuticals, and consists of a biodegradeable wafer implanted at the time of surgery that delivers chemotherapy directly to the tumor site and minimizes drug exposure to the rest of the body.

Gliadel was approved in the USA last year based on the results of a 222-patient study (Marketletter September 30, 1996). This found that patients with glioma who were treated with Gliadel had an increase in survival of more than 50% at six months (from 36% to 56%). Side effects were consistent with those normally encountered after surgery for the condition. The incidence of seizures was the same in both groups, although the Gliadel group tended to experience them earlier on.