FDA Update: September/October 2011

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A new drug for certain patients with locally advanced or metastatic non-small 
cell lung cancer (NSCLC), 
crizotinib (Xalkori), is approved along with a companion diagnostic test to determine whether a person has the abnormal anaplastic lymphoma kinase (ALK) gene. Crizotinib works by blocking kinases, including the protein produced by the abnormal ALK gene. 

The FDA approved a treatment for Hodgkin lymphoma, brentuximab vedotin (Adcetris), and has also made it the first to be specifically indicated for the treatment of a rare malignant tumor known as systemic anaplastic large cell lymphoma (ALCL). Brentuximab uses an antibody to direct the drug to a target on lymphoma cells known as CD30. It is to be used after Hodgkin lymphoma has progressed following autologous stem cell transplant, or—in those who cannot undergo a transplant—after two prior chemotherapy treatments. 

The boxed warning for the entire class of tumor necrosis factor (TNF) alpha blockers has been updated to reflect the risk of infection from two bacterial pathogens, Legionella and Listeria. In addition, the boxed warning and Warnings and Precautions sections of the labels for all TNF-alpha blockers have been revised to include consistent information about the risk for serious infections and the associated disease-causing pathogens. 

Fujirebio Diagnostics, Inc. received 510(k) clearance from the FDA to market a biomarker test for ovarian cancer. The company will market its HE4 blood test in an algorithm called ROMA (HE4 EIA + ARCHITECT CA 125 II) to identify patients with adnexal mass who are likely to have malignancy, and thus should have their surgery performed by a gynecologic oncologist. HE4 has been shown to be elevated in epithelial ovarian cancers but is not elevated in many benign gynecologic diseases.

The FDA has notified health care professionals and patients of an ongoing safety review and labeling changes for the antinausea drug ondansetron (Zofran ODT, generics; ondansetron hydrochloride [Zofran, generics]). This 5-HT3 receptor antagonist, which is used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, and surgery, may increase the risk for prolongation of the QT interval of the electrocardiogram. This, in turn, can lead to an abnormal and potentially fatal heart rhythm. ONA

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