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PART 1 FIRST-IN-CLASS AGENTS
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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.
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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 shortage ...