Rituximab (Rituxan - Genentech), an anti-CD20 monoclonal antibody already marketed for treatment of B-cell non-Hodgkin's lymphoma, is now FDA-approved for use concurrently with methotrexate to treat moderate to severe rheumatoid arthritis in patients who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitors. Rituximab selectively depletes CD20+ B cells, which apparently play a role in the autoimmune response and in the chronic synovitis associated with rheumatoid arthritis.

Decitabine (Dacogen - MGI Pharma), a pyrimidine nucleoside analog of cytidine, was approved by the FDA as an orphan drug for treatment of myelodysplastic syndromes (MDS), a heterogeneous group of clonal hemopathies that decrease production of normal blood elements (red cells, white cells and platelets) and are associated with a risk of progression to acute leukemia.

The FDA has approved Exforge (Novartis) and Azor (Daiichi Sankyo), the first combinations of a calcium channel blocker (CCB) with an angiotensin receptor blocker (ARB) for treatment of hypertension. Amlodipine is the CCB in both products. The ARBs are valsartan in Exforge and olmesartan in Azor. All 3 of these drugs are available in fixed-dose combinations with other antihypertensive drugs.

Temsirolimus (Torisel - Wyeth), an mTOR (mammalian target of rapamycin) kinase inhibitor that is metabolized to sirolimus (rapamycin), has been approved by the FDA for intravenous treatment of advanced renal cell carcinoma.

The FDA has approved the use of the 5α-reductase inhibitor dutasteride (Avodart - GlaxoSmithKline) together with the alpha₁-blocker tamsulosin (Flomax - Boehringer Ingelheim) for treatment of benign prostatic hyperplasia (BPH). Use of an alpha1-blocker with a 5α-reductase inhibitor has been a common practice for years, but FDA approval of a particular combination permits the manufacturers to add an indication for it in both package inserts, recommend dosage for combination use, and advertise the benefits of using the 2 drugs together.

The FDA has approved the marketing of alvimopan (Entereg - Adolor/GlaxoSmithKline), a selective muopioid receptor antagonist, for oral treatment of postoperative ileus after bowel resection. The only other drug in this class available in the US is subcutaneously injected methylnaltrexone (Relistor), which is approved for treatment of opioid-induced constipation in patients with advanced illness receiving palliative care.

Effective treatment of hypertension can prevent organ damage and death. The choice of drugs for initial treatment continues to be controversial.

The FDA has cleared a new device for treatment of major depressive disorder (MDD) resistant to antidepressant medication. The NeuroStar TMS System (Neuronetics) produces pulsed magnetic fields that can induce electrical currents in the brain. Unlike electroconvulsive therapy (ECT), it does not require anesthesia or induction of seizures. Other similar devices are under development.

Several large European observational studies published on-line this summer have raised questions about whether use of insulin glargine increases the risk of cancer.

The FDA has approved the use of aliskiren (Tekturna), a direct renin inhibitor, with valsartan (Diovan), an angiotensin-receptor blocker (ARB), in a fixed-dose combination as Valturna (Novartis) for treatment of hypertension in patients already taking both drugs or not adequately controlled on monotherapy, and as initial therapy in those likely to need multiple drugs to control their blood pressure.