The FDA has approved 2 new treatments for castration-resistant (formerly called hormone-refractory) prostate cancer. Sipuleucel-T (Provenge – Dendreon) is the first immunotherapy approved for treatment of prostate cancer. Cabazitaxel (Jevtana – Sanofi-Aventis) is approved for second-line treatment of metastatic castration-resistant prostate cancer previously treated with docetaxel (Taxotere).

The injectable direct thrombin inhibitor desirudin (Iprivask – Canyon), a recombinant analog of hirudin, the leech anticoagulant protein, was approved by the FDA in 2003 for prevention of venous thromboembolism (VTE) after elective hip arthroplasty, but was only marketed recently in the US. It has been available in Europe as Revasc for about 10 years. Two other hirudin analogs are available in the US: lepirudin (Refludan) for treatment of heparin-induced thrombocytopenia (HIT) and bivalirudin (Angiomax) for use in percutaneous coronary intervention (PCI).

Perampanel (per am’ pa nel; Fycompa – Eisai), a first-in-class noncompetitive AMPA receptor antagonist, has been approved by the FDA for adjunctive treatment of partial-onset seizures in patients ≥12 years old. New drugs for epilepsy are often initially approved by the FDA as adjunctive treatment for partial seizures.

The FDA has approved golimumab (Simponi – Janssen), a fully human monoclonal antibody specific for tumor necrosis factor (TNF) alpha, for induction and maintenance of remission in patients with moderate to severe ulcerative colitis who do not respond to or cannot tolerate other therapies or who require continuous treatment with corticosteroids. Golimumab was approved earlier for treatment of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. It is the third TNF inhibitor to be approved for use in ulcerative colitis.

Opdualag (BMS), a fixed-dose combination of two immune checkpoint inhibitors — nivolumab (Opdivo), a programmed death receptor-1 (PD-1) inhibitor, and relatlimab-rmbw, a lymphocyte-activation gene-3 (LAG-3) blocking antibody — has been approved by the FDA for treatment of unresectable or metastatic melanoma in patients ≥12 years old. Relatlimab, which is only available in combination with nivolumab, is the first LAG-3 blocking antibody to become available in the US. Immune checkpoint inhibitors, including the anti-CTLA-4 antibody ipilimumab (Yervoy) and the PD-1 inhibitors...

Emrosi (Journey), an oral, low-dose, biphasic-release formulation of the tetracycline antibiotic minocycline, has been approved by the FDA for once-daily treatment of inflammatory lesions of rosacea (papules and pustules) in adults. Low-dose, biphasic-release doxycycline (Oracea, and generics) has been available for years for treatment of papulopustular rosacea.

Percutaneous coronary intervention (PCI), such as balloon angioplasty or stent placement, predisposes to subsequent thrombosis. The current pharmacologic approach to prevention of this problem combines an anticoagulant with one or more antiplatelet drugs.

Levocetirizine (Xyzal - UCB/Sanofi-aventis), the active enantiomer of the second-generation H₁-antihistamine cetirizine (Zyrtec), has been approved by the FDA for treatment of seasonal and perennial allergic rhinitis (SAR and PAR) and chronic idiopathic urticaria in adults and children 6 years of age and older. Cetirizine has been approved by the FDA for over-the-counter use and may also become available generically in the US. Levocetirizine has been available in Europe since 2001.

Antiplatelet drugs are the drugs of choice for prevention and treatment of arterial thrombosis. Anticoagulants are the drugs of choice for prevention and treatment of venous thromboembolism and for prevention of cardioembolic events in patients with atrial fibrillation.

Mild to moderate plaque psoriasis can be treated with topical drugs and phototherapy. Patients with moderate to severe disease generally require systemic therapy. Guidelines for the treatment of psoriasis with topical therapy, phototherapy, and systemic drugs have recently been published.