SILVER SPRING, Md-In addition to recommending approval of Taxotere
(docetaxel) at its most recent meeting (see " Panel Recommends
Taxotere Be Approved for Advanced Breast Cancer"), the FDA's
Oncologic Drugs Advisory Committee (ODAC) also voted on two other
new drug applications and heard a presentation on a new imaging
The panel voted 8 to 2 to recommend approval of Orion-Farmos'
antiestrogen Fareston (toremifene citrate), 60 mg/day, for the
treatment of locally advanced and advanced breast cancer in postmenopausal
women. In three studies in the United States, Norway, and the
former USSR, the safety profile of Fareston was shown to be similar
to that of tamoxifen (Nolvadex). Schering-Plough has US marketing
rights to Fareston.
The FDA panel also voted unanimously to recommend approval of
Zeneca Pharmaceuticals' Arimidex (anastrozole) for the treatment
of postmenopausal women with advanced breast cancer following
The agent, a nonsteroidal compound, is the first entry in a new
class of selective oral aromatase inhibitors. Inhibition of aromatase
reduces the production of estrogen. Because anas-trozole has a
long half-life (50 hours), once-daily dosing is adequate.
Two trials, conducted in North America, Europe, Australia, and
South Africa, showed that 1 mg/day of Arimidex obtained the same
results as a 10 mg/day Arimidex dose or 160 mg/day of meges-trol
acetate, the company said. While survival rates and quality of
life were equal for all three groups, significant weight gain
occurred in patients on megestrol.
The FDA panel also listened to a presentation from Immunomedics,
Inc. on its monoclonal antibody imaging agent CEA-Scan (arcitumomab).
The company is seeking FDA approval of the agent for diagnostic
imaging in presurgical patients who are being considered for resection
of recurrent/metastatic colorectal cancer and, in combination
with standard diagnostic modalities, for more accurate localization
of CEA-producing colorectal cancers.
Phase III studies have shown that CEA-Scan identified colorectal
cancers of 1 cm or less that had been missed by CT scans. In trials
conducted at more than 20 US sites, the antibody consistently
found tumors that could not be detected by other methods and were
histologically confirmed, the company said.