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Issues
2012
February 2012, Vol 3, No 1
February 2012, Vol 3, No 1
Gleevec Approved for Children with Acute Lymphoblastic Leukemia
FDA Approvals, News & Updates
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.
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Boxed Warning, New Contraindication Added to Brentuximab’s Label
FDA Approvals, News & Updates
February 2012, Vol 3, No 1
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.
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Bosutinib NDA Accepted for CML
FDA Approvals, News & Updates
February 2012, Vol 3, No 1
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).
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Topical Gel for Actinic Keratosis
FDA Approvals, News & Updates
February 2012, Vol 3, No 1
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.
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Subcutaneous Bortezomib a New Therapeutic Option
FDA Approvals, News & Updates
February 2012, Vol 3, No 1
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.
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FDA Approves Axitinib for Advanced Renal-Cell Carcinoma
FDA Approvals, News & Updates
February 2012, Vol 3, No 1
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.
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Erivedge First Drug Ever for Metastatic Basal-Cell Carcinoma
FDA Approvals, News & Updates
February 2012, Vol 3, No 1
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.
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BCL2 Inhibitor Navitoclax Shows Antileukemic Activity in CLL
In the Literature
February 2012, Vol 3, No 1
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).
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Chemotherapy-Induced Structural Brain Changes Linked to Cognitive Function
In the Literature
February 2012, Vol 3, No 1
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).
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33 States Not Prepared to Cover Patients in Clinical Trials by 2014
In the Literature
February 2012, Vol 3, No 1
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.
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Association for Value-Based Cancer Care
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Value-Based Care in Myeloma
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