FDA approves Eisai’s Dacogen
WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a five-day dosing regimen for an injectable drug made by Eisai for treating bone marrow disease, Eisai announced.
The drug, Dacogen (decitabine) treats myelodysplastic syndromes, which alter the production of blood cells. Eisai said the new option allows outpatient dosing that will provide reduced infusion time.
The drug can be administered via IV for one hour a day for five days ever four weeks. The previous regimen required infusion for three hours repeated every eight hours for three days, repeated every six weeks.
Late-stage clinical trial of Avastin fails to meet expectations, Genentech says
SOUTH SAN FRANCISCO, Calif. A late-stage clinical trial of a Genentech drug for men with late-stage prostate cancer has failed, the biotech company announced Friday.
Genentech, part of Swiss drug maker Roche, announced that a phase 3 trial of Avastin (bevacizumab) combined with prednisone and the chemotherapy drug docetaxel did not extend the amount of time that patients survived, compared with chemotherapy and prednisone alone.
The drug already has approval from the Food and Drug Administration for treating tumors and cancers of the lungs, colon, rectum, breasts, kidneys and brain.
Abbott’s submits supplemental approval application for Lupron Depot to FDA
ABBOTT PARK, Ill. Abbott is hoping that the Food and Drug Administration will approve one of its drugs as a treatment for advanced prostate cancer.
The Chicago-based drug maker announced Thursday that the FDA accepted its supplemental approval application for Lupron Depot (leuprolide acetate) in the 45-mg strength. The drug, an injectable, works by suppressing production of testosterone for six months. It is currently available in 7.5-mg, 22.5-mg and 30-mg formulations that work for one, three and four months.
“For many patients with advanced prostate cancer, Lupron Depot is an important treatment option because it can help manage the symptoms of their disease,” Abbott VP global pharmaceutical development Eugene Sun said in a statement. “Abbott is seeking approval for a new six-month formulation to provide greater convenience and dosing flexibility to physicians and patients who could benefit form this medication.”