Following completion of Phase III trials of DaunoXome, Vestar Inc.has filed an amended new drug application with the FDA forapproval of the drug for Kaposi's sarcoma in patients who cannottake chemotherapy or for whom conventional treatments have failed.
The amended NDA was filed about 18 months after the FDA'sOncologic Drugs Advisory Committee (ODAC) in June 1993rejected DaunoXome. The initial NDA was based on Phase II trialdata.
Michael Hart, executive vice president and chief financial officer forthe San Dimas, Calif.-based Vestar, said one FDA requirement for anamended NDA was completion of Phase III trials, which compareDaunoXome with standard combination chemotherapy involvingbleomycin, vincristine and adriamycin. DaunoXome is a liposomalformulation of daunorubicin.
Hart said among the reasons ODAC voted in 1993 not to approve thedrug were differences between the regulatory officials and Vestarinvestigators over data interpretation. For that reason, Hart added,the company has decided not to release results of the Phase III trialsuntil the new ODAC hearing.
"Obviously by submitting the amended NDA we think there'stherapeutic value in DaunoXome," Hart said.
In addition to seeking approval in the U.S., Vestar has filedmarketing applications in France, Sweden and the U.K.
Vestar's stock (NASDAQ:VSTR) closed Tuesday at $5.12, down 25cents. n
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