FDA Grants Orphan Drug Status for Cephalon's Lestaurtinib

May 1, 2006
Oncology NEWS International, Oncology NEWS International Vol 15 No 5, Volume 15, Issue 5

FDA Grants Orphan Drug Status for Cephalon's Lestaurtinib

FRAZER, Pennsylvania—The FDA has granted orphan drug status to Cephalon, Inc.'s lestaurtinib (CEP-701) for acute myeloid leukemia (AML). The oral compound inhibits several tyrosine kinases including FLT-3 and TrkA. It is in phase II/III trials for AML patients at first relapse who have a FLT-3 activating mutation.