Enzon Inc., Rhone-Poulenc Rorer cancer news
ENZN agreed with the FDA to implement temporary labeling and distribution modifications for Oncaspar PEG- L-asparaginase used in combination chemotherapy for patients with acute lymphoblastic leukemia (ALL) who are hypersensitive to other treatments. The company had discovered particulate matter in some vials of Oncaspar.
Until the problem is resolved, ENZN will distribute Oncaspar directly to patients on an as-needed basis and the label will be modified to limit Oncaspar's use to intramuscular injection. ENZN said it will receive the full list price of Oncaspar and expects RPR, its U.S. distributor, to resume distribution when the problem is corrected. RPR has voluntarily instituted an urgent drug notification under which 600 vials of Oncaspar will be returned to ENZN. ...