eChapter 69 (Part 1): The Goodman & Gilman Year in Review: 2013 New and Noteworthy FDA Approvals

PART 1 FIRST-IN-CLASS AGENTS

The FDA approved 40 new drugs and biologics of note in 2013. Twenty-two are pharmacologically similar to others already marketed and 10 are newly licensed biologics (see part 2 of this series). The remainder represent eight first-in-class agents indicated for the management of cancer, diabetes, hepatitis C infection, hypercholesterolemia, multiple sclerosis, and pulmonary hypertension (Table 69-1). Three drugs, ibrutinib (IMBRUVICA) for lymphoma (Table 69-1), obinutuzumab (GAZYVA) for chronic lymphocytic leukemia (see part 2 of this series), and sofosbuvir (SOVALDI) for hepatitis C infection (Table 69-1), were the first drugs to be approved under FDA's "breakthrough therapy" designation.1 Established in 2012, FDA reserves breakthrough designations for drugs exhibiting superior efficacy against serious diseases.

Among previously approved drugs, one product, pertuzumab (PERJETA), became the first FDA-approved neoadjuvant treatment for breast cancer.2 Neoadjuvant treatments are given as a first step to shrink a tumor before the main treatment (usually surgery) is given. Another new product, clinolipid (see part 2 of this series) was granted a priority review to help alleviate the long-standing national ...