2012: Banner Year for New Drugs

Fueled by new cancer therapeutics, last year the annual new molecular and biological entity approval count from the U.S. Food and Drug Administration (FDA) saw its highest year since 1997. One-third of the novel products approved by the FDA’s Center for Drug Evaluation and Research (CDER) are used to treat cancers of the blood, breast, colon, prostate, skin and thyroid. As part of the U.S. Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) promotes and protects the health of Americans by assuring that all prescription and over-the-counter drugs are safe and effective. The CDER evaluates all new over-the-counter and prescription drugs, including biological therapeutics and generic drugs, before they are sold. The 39 novel approvals for 2012 encompass a number of new cancer therapies, including Roche’s Erivedge, the first FDA-approved drug for late-stage basal cell cancer, the most common form of skin cancer, Genentech’s Perjeta, approved for the 20% of breast cancer patients with HER2 positive cancers, and Medivation’s Xtandi, approved for castration-resistant prostate cancer, one of a new class of drugs known as androgen inhibitors, designed to interfere with the ability of testosterone to bind to prostate cancer cells. Testosterone is the male hormone that fuels prostate cancer cell growth. A detailed list of all new approved therapeutics is shown in the table below. Positron Emission Tomography (PET) is an imaging tec...
Source: Highlight HEALTH - Category: Medical Scientists Authors: Source Type: blogs