Guilford To Seek Broad Use For Gliadel

Guilford will meet soon with the US Food and Drug Administration to try and get approval for its Gliadel Wafer (carmustine) brain cancer treatment for use in all surgeries, rather than only in follow-up interventions. Nicholas Landekic, Guilford's vice president of business development, said that the agency is likely to make a decision before the end of the year.

Last month, an FDA advisory committee recommended that Glidel Wafer be approved for use in recurrent brain surgery but not in initial surgery. The biodegradeable wafer, several of which are implanted into the cavity left when a tumor is removed, slowly dissolve and release the anticancer agent. In a recent report, Alex Zisson of Hambrecht & Quist said he expected surgeons to use Gliadel off-label in primary surgeries, even if the FDA follows the narrower panel recommendation.