Chiron Corp. and Cytogen Corp. announced Friday that they willhave products reviewed by a Food and Drug Administrationpanel in January.
Chiron's Proleukin interleukin-2 to treat metastatic renal cellcarcinoma, acquired as part of the purchase of Cetus Corp., willbe reviewed on Jan. 17 by the Biological Response Modifiersadvisory committee.
Emeryville, Calif.-based Chiron shares (NASDAQ:CHIR) rose $1to $62.75.
This is the drug's second time before the committee. In July1990, the panel delayed approval, asking Cetus to identify thespecific subpopulation of patients that benefits from the drug.
Proleukin is marketed in 10 European countries and hascurrent annualized sales of $15 million.
Cetus Oncology is sponsoring Phase I or II trials of the drug,alone or in combination with other agents, to treat melanoma,breast cancer, solid tumors and papilloma virus infections. Inaddition, the company is supplying Proleukin to otherinstitutions that are sponsoring Phase I or II trials in severalother indications.
Cytogen said the committee will review on Jan. 16 its OncoScintOV103 and OncoScint CR103 monoclonal antibody-basedimaging agents.
OncoScint links tumor-specific MAbs with the isotope indium-111. OV103 targets ovarian cancer and CR103 targets colorectalcancer.
The Princeton, N.J., company predicted a product launch inApril 1992 and expects to break even by the end of 1993. Thecompany estimated the U.S. market for colorectal cancerimaging at $200 million and the U.S. market for ovarian cancerimaging at $25 million, with equivalent markets in Europe andAsia.
Cytogen shares (NASDAQ:CYTO) closed up 13 cents at $15.
OncoScint CR103 has received marketing approval in severalEuropean countries and is marketed by EuroCetus. Cytogen willfile in mid-January for CPMP approval of OV103 via anamendment to its original CR103 filing and expects arecommendation for approval around July.
-- Karen Bernstein BioWorld Staff
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