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Biotech / Medical : Pharma News Only (pfe,mrk,wla, sgp, ahp, bmy, lly)
PFE 25.28+0.1%3:59 PM EST
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To: Henry Niman who wrote (1066)11/17/1998 11:20:00 AM
From: Anthony Wong   of 1722
 
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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