Natalizumab (Tysabri - Elan and Biogen) is a monoclonal antibody approved for induction and maintenance treatment of moderate to severe Crohn's disease (CD) refractory to conventional therapies and inhibitors of tumor necrosis factor (TNF). Initially approved in 2004 for the treatment of multiple sclerosis (MS), natalizumab was temporarily withdrawn from the market after 3 patients developed progressive multifocal leukoencephalopathy (PML). It is now available for treatment of both MS and CD through a restricted distribution program.

Two new platelet glycoprotein IIb/IIIa receptor antagonists have been approved for marketing by the US Food and Drug Administration (FDA). Eptifibatide (ep ti fi' ba tyde; Integrilin - Cor, Key) is approved for use in acute coronary syndromes (unstable angina or non-Q-wave myocardial infarction) or percutaneous coronary intervention (angioplasty or atherectomy). Tirofiban (tye roe fye' ban; Aggrastat - Merck) is approved for acute coronary syndromes, but not for angioplasty without an acute coronary syndrome. Abciximab (ReoPro), a monoclonal antibody glycoprotein IIb/IIIa receptor...

The FDA has approved a new plasma-derived von Willebrand factor/Factor VIII concentrate (Wilate – Octapharma) for treatment of spontaneous and trauma-induced bleeding episodes in patients with von Willebrand disease.

The FDA has approved sacituzumab govitecan-hziy (Trodelvy – Immunomedics), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with metastatic triple-negative breast cancer who have received ≥2 prior therapies for metastatic disease. It is the first Trop-2-directed antibody-drug conjugate to become available in the US.

View the Comparison Table: Some Drugs for Postmenopausal Osteoporosis

Aprotinin (Trasylol - Miles), an inhibitor of fibrinolysis first identified in 1930, was recently approved by the US Food and Drug Administration for intravenous use in high-risk coronary artery bypass graft (CABG) surgery to decrease bleeding and the need for transfusion. Inhibitors of fibrinolysis previously available in the USA include aminocaproic acid (Amicar, and others) and tranexamic acid (Cyklokapron - Medical Letter, 29:89, 1987).

Ado-trastuzumab emtansine (Kadcyla – Genentech), a human epidermal growth factor receptor 2 (HER2)-targeted antibody and microtubule inhibitor conjugate, has been approved by the FDA for intravenous (IV) treatment of HER2-positive metastatic breast cancer in patients previously treated with trastuzumab (Herceptin) and a taxane. The prefix was added to the new conjugate’s name at the request of the FDA to distinguish it from trastuzumab.

The FDA has approved sebelipase alfa (Kanuma – Alexion), a recombinant form of lysosomal acid lipase (LAL), for enzyme replacement therapy in patients with LAL deficiency. Sebelipase alfa is the first drug to be approved in the US for treatment of LAL deficiency, a rare autosomal recessive storage disease.

Carboplatin (Paraplatin - Bristol-Myers), a cytotoxic platinum-containing drug chemically related to cisplatin (Platinol), was recently approved by the US Food and Drug Administration (FDA) for palliative treatment of patients with recurrent ovarian cancer, including those previously treated with cisplatin.

Pentostatin (2'-deoxycoformycin; DCF; - Parke-Davis), a purine analog, was recently approved by the US Food and Drug Administration (FDA) for treatment of hairy-cell leukemia resistant to interferon alfa (Intron A; Roferon-A). is a rare (500 cases/year in the USA) form of chronic lymphocytic leukemia. Acutely ill patients may respond rapidly to interferon, but the drug is rarely curative. Another purine analog, 2-chlorodeoxyadenosine (CdA; Leustatin - Ortho Biotech), may also be approved soon for treatment of hairy-cell leukemia (JD Piro, Blood, 79:843, 1992). Fludarabine (Fludara...