Why is the FDA fast tracks Spectrum, Allergan cancer drug?
Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer. The drug candidate received fast track status from the FDA. The fast track designation is intended to speed up the development and review of drugs that treat serious illnesses, including those for which no treatment exists, or that could be a significant improvement over drugs currently on the market. The companies are enrolling patients in a late-stage clinical trial of the drug. EOquin, or apaziquone, is intended to treat bladder cancer that has not that has not yet spread deep into the muscle layer. Spectrum and Allergan estimated that the non-muscle invasive type accounts for 70 percent of new bladder cancer diagnoses, and said it affects more than a million patients in the U.S. and Europe. Spectrum shares rose 33 cents, or 5.6 percent, to $6.20 in premarket trading. Al
FDA fast tracks Spectrum, Allergan cancer drug July 21, 2009 9:30 AM ET NEW YORK (AP) – Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer. The drug candidate received fast track status from the FDA. The fast track designation is intended to speed up the development and review of drugs that treat serious illnesses, including those for which no treatment exists, or that could be a significant improvement over drugs currently on the market. The companies are enrolling patients in a late-stage clinical trial of the drug. EOquin, or apaziquone, is intended to treat bladder cancer that has not that has not yet spread deep into the muscle layer. Spectrum and Allergan estimated that the non-muscle invasive type accounts for 70 percent of new bladder cancer diagnoses, and said it affects more than a million patients in the U.S. and
NEW YORK — Spectrum Pharmaceuticals Inc. and Allergan Inc. said Tuesday the Food and Drug Administration will grant a faster review to their drug candidate EOquin, which is intended to treat non-muscle invasive bladder cancer. Sources: google.
