FDA Recommends Additional Trial of NeoPharm's GBM Treatment

NeoPharm that it has met with the FDA's Office of Oncology to discuss data from the company's Phase III PRECISE trial, which evaluated cintredekin besudotox for the treatment of recurrent glioblastoma multiforme (GBM).

The company announced in December 2006 that the trial did not meet the primary efficacy endpoint, which was a statistically significant difference in overall survival compared with the Gliadel Wafer. The study showed that cintredekin besudotox, while comparable, was not superior to Gliadel.

Following NeoPharm's presentation of the data, the FDA's position was that an additional Phase III clinical trial of the drug in the treatment of GBM would be required before the agency could accept an application. However, the Office of Oncology did encourage the company to maintain a dialogue with the agency regarding the path forward.

NeoPharm said it is disappointed with the FDA's recommendation, which, if implemented, would significantly delay the launch of this therapy for GBM patients. The company said it will consider its options to determine the best plan.