Levamisole (Janssen), an old antiparasitic drug widely used for treatment of ascariasis in animals, is now available from the National Cancer Institute (NCI) for investigational use with fluorouracil (5-FU; Adrucil; and others) as an adjuvant for treatment of resectable colon cancer that has metastasized to regional lymph nodes (Dukes stage C).

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...

Rituximab (Rituxan - IDEC Pharmaceutical/Genentech), a monoclonal antibody, has been approved by the FDA for treatment of low-grade B-cell non-Hodgkin's lymphoma. Most low-grade lymphomas are B-cell lymphomas.

The FDA has approved abiraterone acetate (Zytiga – Centocor Ortho Biotech) for oral treatment, in combination with prednisone, of metastatic castration-resistant prostate cancer in patients previously treated with docetaxel (Taxotere, and others). It is the first oral drug approved for this indication. Zytiga will compete with cabazitaxel (Jevtana) and sipuleucel-T (Provenge).

Radium Ra 223 dichloride (Xofigo – Bayer), a radiotherapeutic drug, has been approved by the FDA for intravenous treatment of castration-resistant prostate cancer with symptomatic bone metastases and no known visceral metastatic disease.

Obinutuzumab (Gazyva – Genentech), a humanized anti-CD20 monoclonal antibody, has been approved by the FDA for use in combination with chlorambucil (Leukeran) in patients with previously untreated chronic lymphocytic leukemia (CLL). Two other anti-CD20 antibodies, rituximab (Rituxan) and ofatumumab (Arzerra), were previously approved for treatment of CLL.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor abemaciclib (Verzenio – Lilly), which was approved by the FDA in 2017 for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of patients with HR-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%.

Monoclate (Armour), a formulation of Factor VIII (antihemophilic factor; AHF) prepared by immunoaffinity chromatography, was recently approved for marketing by the US Food and Drug Administration. The new product is claimed to be more highly purified than older AHF formulations. Factor VIII concentrates commercially available in the USA are listed in the table below.

HA-1A (Centoxin - Centocor), a monoclonal IgM antibody against endotoxin from gram-negative bacteria, may soon be approved for marketing by the US Food and Drug Administration. Commercially available in Europe, HA-1A has been used in the USA as an investigational drug. E5 (Xomen - Xoma), another monoclonal IgM antibody against endotoxin, is also available here for investigational use.

Anastrozole (Arimidex - AstraZeneca, Medical Letter 1996; 38:61), an aromatase inhibitor, has received accelerated approval from the FDA for adjuvant treatment of postmenopausal women with early hormone-receptor-positive breast cancer. The drug was approved for treatment of postmenopausal women with metastatic breast cancer in 1996.