Eisai also gained rights to the Gliadel
Wafer, a chemotherapy agent, and Dacogen for myelodysplastic syndromes.
For recurrent GBM also not suitable for resection, a retrospective study by Kim et al., showed correlation of MGMT promoter methylation status with better progression free survival (PFS), and OS in patients who underwent gamma knife radiosurgery.8 MGMT methylation, and low MGMT expression were also identified as favourable prognostic markers in patients with newly diagnosed GBM, who underwent implantation of carmustine releasing wafers (Gliadel
) after surgery.9
1997: The FDA approved Gliadel
wafers for the treatment of recurrent GBM.
Westphal et al., "Phase III randomized trial of CED of IL13-PE38QQR vs Gliadel
wafers for recurrent glioblastoma," Neuro-Oncology, vol.
Subsequently, the patient was transferred to an outlying institution for additional management where he underwent reopening craniotomy with microsurgical resection of the tumor with Gliadel
wafer placement approximately 17 weeks from his initial resection.
Bortey et al., "A phase 3 trial of local chemotherapy with biodegradable carmustine (BCNU) wafers (Gliadel
wafers) in patients with primary malignant glioma," Neuro-Oncology, vol.
This trial enrolled 296 patients; one arm received IL-13PE and another received carmustine-releasing gliadel
wafers (GW) via catheters implanted in the walls of the resection cavity after craniotomy.
Safety and efficacy of Gliadel
wafers for newly diagnosed and recurrent glioblastomas.
In addition to Halaven being launched, the company currently has submitted the anticancer agent Gliadel
, the antiepileptic agents Fycompa and Inovelon as well as the antiobesity agent BELVIQ for review.
Over the years, the wafer-based drug delivery technology originally conceived for a general drug delivery tool was developed to become the Gliadel
, a wafer licensed by Esai Inc.