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| |  FDA Committee Recommends DepoCyt For Lymphomatous Meningitis SAN DIEGO, CA and EMERYVILLE, CA -- Nov. 17, 1998 -- The United States Food and Drug Administration’s oncologic drugs advisory committee has recommended accelerated approval of DepoTech Corp.’s and Chiron Corp.’s anti-cancer drug DepoCyt(TM), for intrathecal treatment of lymphomatous meningitis. DepoCyt is an injectable sustained-release formulation of the chemotherapeutic agent cytarabine, (Ara-c), that is based on DepoTech's proprietary DepoFoam(TM) technology. If approved by the FDA, it will be marketed in the U.S. by Chiron. Lymphomatous meningitis is a subtype of neoplastic meningitis (NM). NM occurs when metastases from lymphomas, solid tumours, or leukemia, spread to the tissue surrounding the brain and spinal cord. DepoTech and Chiron are continuing pivotal Phase III studies of DepoCyt in NM arising from lymphomas and leukemia. In addition, a multi-centre Phase IV study for the treatment of NM arising from solid tumours is underway in the U.S. and Canada to collect further data related to safety and efficacy. Moreover, a Phase I pediatric dose-finding study is ongoing to assess the use of DepoCyt in children. The most common side effects observed in the study were headache and arachnoiditis, a syndrome characterised by neck pain, vomiting and headache.
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