February 2012, Vol 3, No 1

The US Food and Drug Admini­s­tration (FDA) approved a new indication for imatinib (Gleevec; Novartis) for the treatment of children with newly diagnosed Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia (ALL), the most common type of pediatric cancer.

The FDA has issued a boxed warning for brentuximab vedotin (Adcetris, Seattle Genetics) related to the risk of John Cunningham virus infec­tion, leading to progressive multifocal leu­ko­­encephalopathy (PML) and death in patients who take brentuximab to treat Hodgkin lymphoma or systemic anaplastic large-cell lymphoma.

The FDA has accepted a New Drug Application (NDA) for bosutinib (Pfizer), an oral dual Src and Abl tyrosine kinase inhibitor, as a second-line therapy for adult patients with previously treated Philadelphia chromosome–positive (Ph+) chronic myeloid leukemia (CML).

The apoptotic topical gel ingenol mebutate (Picato; Leo Pharma) has received FDA approval for the treatment of actinic keratosis, a precancerous condition that can progress to squamous-cell carcinoma.

The FDA approved a new, subcutaneous route of administration for the proteasome inhibitor bortezomib (Velcade; Millennium) as an alternative method to the previously approved intravenous (IV) form of the drug in all the FDA indications.

The FDA approved the newest oral kinase inhibitor axitinib (Inlyta; Pfizer) for the treatment of patients with advanced renal-cell carcinoma that has failed to respond to previous therapy.

The US Food and Drug Admin­istration (FDA) approved vismodegib (Erivedge; Hoffmann–La Roche), a hedgehog pathway inhibitor, for the treatment of basal-cell carcinoma (BCC) in adults with locally advanced disease who are not candidates for surgery or radiotherapy and in those with metastatic disease.

Results of a phase 1 study show that navitoclax, a new BH3 mimetic that targets BCL2 and related antiapoptotic intracellular proteins in cancer cells, inhibits the development of lympho­cytosis in patients with chronic lymphoyctic leukemia (CLL; Roberts AW, et al. J Clin Oncol. Epub December 19, 2011).

Findings from a longitudinal study of impaired cognitive functioning and cerebral white matter integrity in women who receive chemotherapy for breast cancer suggest that chemotherapy-induced structural changes in the brain are correlated with impaired cognitive functioning (Deprez S, et al. J Clin Oncol. 2012;30:274-281).

In an attempt to eliminate insurance coverage status as a barrier to clinical trial enrollment, the Affordable Care Act of 2010 (ACA) requires that by January 2014, all payers in all states must cover routine medical costs associated with patient participation in approved clinical trials.