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 agent.
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(Drug information on 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 tamoxifen failure.
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(Drug information 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.