UPDATE ON DRUGS
|Approval Dates and Comments
|The Committee for Medicinal Products for Human Use in Europe
recommended approval of this vaccine in July 2006 for the
immunization of children and adolescents aged 9–15 years and
of adult females aged 16–26 years for the prevention of cervical
cancer, high-grade cervical dysplasia (CIN 2/3), high-grade vulvar
dysplastic lesions (VIN 2/3) and external genital warts caused by
human papillomavirus types 6, 11, 16, and 18.
In June 2006 the US Centers for Disease Control and Prevention’s
|The US FDA accepted a supplemental Biologics License Application
in June 2006 for this product for inhibiting the progression of
structural damage and improving physical function in patients with
active psoriatic arthritis.
|The US FDA approved a new device for administering Humira® in
June 2006. Humira® is approved for the treatment of moderate-tosevere
rheumatoid arthritis and psoriatic arthritis. This new device
offers improved ease of use with its one-touch activation and easyto-
grasp size and shape.
|Researchers from the Dana-Farber Cancer Institute have identified a novel gene that facilitates
the spread of malignant melanoma using a technique that they believe can speed the discovery of
hard-to-find cancer genes. Recently reported in Cell*, the gene, NEDD9, is abnormally abundant
in more than a third of melanomas that have metastasized, but not in primary melanomas that have
not spread. The investigators used genome-scanning methods, such as array-CGH (comparative
genomic hybridization), to uncover structural abnormalities of the chromosomes of cancer cells.
*Kim M, Gans JD, Nogueira C, et al. Cell 125(7):1269-81 (2006 Jun).
|In a bold attempt to control scleroderma, physicians at Duke University Medical Center are
leading a national study to test whether stem cell transplants can reconstruct defective immune
systems. At this time, the predominant therapy for this disease is cyclophosphamide; however,
about 50% of patients with severe organ involvement die within 5 years of diagnosis. This study
(Scleroderma Cyclophosphamide or Transplantation – SCOT) will increase the dose and duration
of cyclophosphamide and compare this regimen against stem cell transplants, using purified cells
derived from a patient’s own blood. This 7-year randomized clinical trial will enroll 226 patients at
36 institutions throughout the US. If successful, the therapy would represent the first therapy ever
to treat and potentially reverse the disease itself, not just alleviate its symptoms.