The FDA has approved ofatumumab (Arzerra – GlaxoSmithKline), a human anti-CD20 monoclonal antibody, for treatment of patients with chronic lymphocytic leukemia (CLL) refractory to fludarabine (Fludara, and others) and alemtuzumab (Campath). It is the second anti-CD20 antibody approved for treatment of CLL; rituximab (Rituxan), a chimeric murine/human antibody, was the first.

The FDA has approved pralatrexate (Folotyn – Allos), an intravenous (IV) antifolate, for treatment of adults with relapsed or refractory peripheral T-cell lymphoma (PTCL). It is the first drug approved by the FDA specifically for this indication.

The FDA recently approved Skyla (Bayer), the first new intrauterine device (IUD) in the US in 12 years. It releases levonorgestrel, a synthetic progestin, over a period of 3 years. A table summarizing contraceptive methods available in the US appears on page 22.

The FDA has approved the oral tyrosine kinase inhibitor ripretinib (Qinlock – Deciphera) for treatment of adults with advanced gastrointestinal stromal tumors (GISTs) who have previously received treatment with ≥3 kinase inhibitors, including imatinib (Gleevec, and generics).

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Oat bran, the ground inner husk of the grain, has recently become popular as a dietary means of lowering blood lipids. It is available both separately and as a constituent of oatmeal, which is the ground product of the whole grain. Oat bran and oatmeal are available in various breakfast cereals and can also be used in baked goods, such as muffins or bread. Some of these sources are listed in the table on page 112.

Imatinib mesylate (STI-571; Gleevec - Novartis), an oral tyrosine kinase inhibitor, has received accelerated approval from the FDA for treatment of all phases of chronic myeloid leukemia (CML) after interferon has failed.

The FDA has approved romidepsin (Istodax – Celgene), an IV histone deacetylase (HDAC) inhibitor, for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy. The most common types of CTCL are mycosis fungoides, a low-grade lymphoma usually confined to the skin, and Sézary syndrome, a more aggressive disease with malignant lymphocytes in the blood. Both can progress to fatal systemic involvement. Romidepsin is the second HDAC inhibitor approved for this indication; vorinostat (Zolinza), an oral HDAC inhibitor, was approved...

The FDA has approved an inhaled, rapid-acting, dry-powder formulation of recombinant human insulin (Afrezza – Mannkind/Sanofi) for treatment of adults with type 1 or type 2 diabetes. In patients with type 1 diabetes, the drug must be used in combination with long-acting insulin. Another inhaled, rapid-acting insulin (Exubera) was approved in 2006 for the same indication, but was withdrawn from the market the following year.

The FDA has approved fostamatinib disodium hexahydrate (Tavalisse – Rigel), the first spleen tyrosine kinase (SYK) inhibitor, for oral treatment of thrombocytopenia in adults with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment.