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Weekly News Round Up - November 23, 2011

Erwinaze Approved for E. coli allergic Acute Lymphoblastic Leukemia Patients

Erwinaze approved as adjunct treatment for acute lymphoblastic leukemia in patients with asparaginase-derived E. coli allergy Read More...

Erwinaze (asparaginase Erwinia chrysanthemi) has been FDA-approved as a component of a multi-agent cancer regimen for patients with acute lymphoblastic leukemia (ALL) who have developed an allergy to E. coli- derived asparaginase. Erwinaze, produced from the bacterium Erwinia chrysanthemi, is an asparagine-specific enzyme that depletes the levels of asparagine in the bloodstream, essential for ALL cell growth. As an orphan drug, Erwinaze was evaluated in one clinical trial of 58 patients and was shown to maintain required asparaginase activity at 48 or 72 hours after dosing in all patients. The two E. coli- derived asparagine-specific enzymes available before Erwinaze include Elspar (asparaginase injection) and Oncaspar (pegaspargase).

Lack of Benefit vs. Risk Leads to Withdrawal of Avastin for Breast Cancer

Avastin withdrawn from US market for treatment of metastatic breast cancer Read More...

The Food and Drug Administration (FDA) has withdrawn the metastatic breast cancer indication for Avastin (bevacizumab). Avastin will remain available for certain types of colon, lung, kidney and brain cancer. Studies completed after Avastin approval found that the drug had a small effect on tumor growth, no evidence of reduced mortality, and no increase in quality of life compared to standard cancer regimens. The decision is controversial, with some clinicians stating the drug had a place in treatment. Although a physician may still prescribe Avastin off-label in metastatic breast cancer, the question remains whether or not insurance groups will pay for off-label use of Avastin.

Eylea FDA-Approved for Macular Degeneration

Eylea effective in wet aged-related macular degeneration; efficacy found similar to Lucentis Read More...

Wet aged-related macular degeneration (AMD) is a leading cause of vision loss and blindness in the U.S. Eylea (aflibercept) has been approved as a new treatment option for patients with wet AMD who are typically 60 years and older. Eylea was tested in two clinical trials involving over 2,400 patients. Patients were randomized to either Eylea or Lucentis (ranibizumab), with a primary endpoint of clearness of vision after one year. Eylea was as effective as Lucentis. Common side effects of Eylea included eye pain, blood at the injection site, and visual floating spots (vitrous floaters). In addition to Lucentis, other FDA-approved treatments for wet AMD are Visudyne (verteporfin) and Macugen (pegaptanib sodium).

Cellcept Outperforms Azathioprine for Lupus Kidney Complication

Cellcept (mycophenolate mofetil) in lupus nephritis shown to result in only half as many treatment failures as azathioprine Read More...

Systemic lupus erythematosus (SLE) is an autoimmune disease that may affect the skin, joints, kidneys, brain, and other organs. Many patients experience joint pain and swelling. SLE can also result in lupus nephritis, a serious and potentially life-threatening kidney complication. In a study published this week in the New England Journal of Medicine, mycophenolate mofetil was shown to be associated with a 12.9 percent rate of failure in maintenance treatment of lupus nephritis compared to 32.4 percent of patients receiving the older drug azathioprine. Common adverse events, such as minor infections and stomach disorders, occurred in over 95% of patients regardless of treatment.

Week of Thanksgiving Marks National GERD Awareness Week in U.S.

Gastroesophageal reflux disease is common and can be aggravated during the holidays Read More...

Is your turkey is out of the freezer and thawed by now? And did you find that family-favorite stuffing recipe? This week marks National Gastroesophageal Reflux Disease (GERD) Awareness Week, and the timing is perfect. Roughly 30 million Americans have GERD, and the holidays can cause reflux to churn out of control. Symptoms may appear as heartburn, wheezing, sore throat and cough. Holiday delights that may trigger GERD include excess alcohol, fatty-foods, tomato-based products, chocolate, peppermint, citrus and coffee. Experts urge if you suspect GERD seek diagnosis prior to the holidays. Over-the-counter treatments, such as Prilosec OTC (omeprazole), Pepcid AC (famotidine), or Gaviscon Liquid may offer relief. Now where is that pumpkin pie?