DOW JONES NEWSWIRES
Centocor Ortho Biotech Products LP, a unit of Johnson &
Johnson (JNJ), received a complete response letter from the Food
and Drug Administration regarding the company's supplemental new
drug application for the use of Doxil in a combination therapy for
advanced breast cancer.
In July, an FDA committee made a nonbinding recommendation
indicating the combination with docetaxel didn't provide a
sufficient benefit for its risk.
On Thursday, Centocor, which markets the drug in the U.S., said
it is evaluating the letter and will respond as quickly as
possible. The company filed the application a year ago for the
drug, which is already used to treat other cancers.
The drug carries a boxed warning that alerts users to possible
cardiac toxicity and liver impairment, as well as other potential
side effects.
Janssen-Cilag markets the drug in Israel, while Schering-Plough
Corp. (SGP) markets it as Caelyx in the rest of the world, except
for Japan and Israel.
Johnson & Johnson shares were unchanged at $60.66 in
after-hours trading.
- By Jay Miller, Dow Jones Newswires; 212-416-2355;
jay.miller@dowjones.com