Articles

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.

Two phase 3 international clinical studies show that initiating therapy with bevacizumab in combination with standard chemotherapy extends progression-free survival (PFS) in women with advanced ovarian cancer, and women at high risk for disease progression may live longer with the addition of bevacizumab to standard therapy (Burger RA, et al. N Engl J Med. 2011;365:2473-2483; Perren TJ, et al. N Engl J Med. 2011;365:2484-2496).

he addition of pertuzumab to trastuzumab and docetaxel as first-line therapy for women with HER2-positive metastatic breast cancer significantly prolongs progression-free survival (PFS) compared with the use of the 2 agents without pertuzumab, according to results of a new phase 3 clinical trial (Baselga J, et al. N Engl J Med. 2012;366:101-119).