US FDA clears J&J, Millennium cancer drug combo
Fri May 18, 2007 7:16pm ET16
[The decision came a week early. Might mean more to Docil than to Velcade, as the former had a relatively limited approved use].
WASHINGTON, May 18 (Reuters) - U.S. regulators said on Friday they had approved combination use of drugs from Johnson & Johnson (JNJ.N: Quote, Profile , Research) and Millennium Pharmaceuticals Inc. (MLNM.O: Quote, Profile , Research) to treat certain cases of multiple myeloma, a blood cancer.
The Food and Drug Administration said it cleared use of J&J's drug Doxil with Millennium's Velcade in patients with multiple myeloma who have not received Velcade previously but have been treated with at least one prior therapy.
A study of 646 patients showed those treated with Velcade alone had their disease progress after a median of 6.5 months following treatment. For patients who also got Doxil, the disease did not start advancing until 9.3 months.
William Foster, spokesman for J&J's Ortho Biotech unit, had no comment on how the wider approval would impact demand or sales, citing company confidentiality.
Foster added that the new combination use for Doxil, an injectable form of doxorubicin hydrochloride, would add an important therapeutic option for cancer patients.
Doxil is already approved to treat ovarian cancer in some patients and AIDS-related Kaposi's sarcoma.
Millennium's Velcade is already approved to treat multiple myeloma in patients who have been treated with at least one prior therapy.
Representatives for Millennium could not be immediately reached for comment on the approval's impact for Velcade, know generically as bortezomib.
Before announcement of the approval, shares of Millennium closed up 4 cents on Friday to $10.92 on the Nasdaq. Shares of J&J closed up 67 cents at $63.42 on the New York Stock Exchange. |
