DepoCyt Heading For Commercialization

Chiron and DepoTech Corporation have reported additional results of a Phase III clinical trial of DepoCyt (sustained-release cytarabine) in patients with neoplastic meningitis arising from solid tumors.

Patients received dosing with DepoCyt every 14 days, compared to twice per week dosing with methotrexate, the standard drug treatment, which served as a control. Of 24 evaluable patients treated with DepoCyt, the median survival was 168 days compared to 87 days for 29 evaluable patients receiving methotrexate. For all solid tumor patients, mean time to neoplastic meningitis disease progression, as measured by neurological examination or death from any cause, was 108 days for those receiving DepoCyt compared to 48 days for those receiving methotrexate.

The companies previously announced that DepoCyt showed a higher complete response rate compared to methotrexate. On the strength of these and other trial data, the companies have agreed that a New Drug Application will be submitted in the USA "as soon as practicable."