OSCO NEWS

Ferumoxytol (Feraheme) Injection - The safety and efficacy of ferumoxytol in the episodic treatment of iron deficiency anemia were assessed in three randomized, open-label, controlled clinical trials enrolling approximately 800 patients with CKD. In all three controlled trials, patients were randomized to either ferumoxytol or oral iron. Two trials evaluated patients with non-dialysis dependent CKD and a third assessed patients undergoing hemodialysis. These trials assessed hemoglobin alterations and clinical outcomes over 35 days. Ferumoxytol was administered as two 510 mg IV injections, with most patients receiving their second injection 3 to 8 days after their initial injection. read more

Related Website: http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf

Medicare Issues Severe Cuts for Community Oncology - CMS has just issued severe cuts to Medicare reimbursement, including a 6% payment cut for community cancer care and elimination of consultation codes. The CMS cut to cancer care is based upon the flawed survey data provided to CMS by the AMA, which is why COA was opposed to the AMA survey. read more

Drug Shortages Update - Morphine Sulfate Oral Solution updated by FDA 5/20/2009 Roxane Laboratories (20mg/5ml and 10mg/5ml) - has product available Mallinckrodt Inc. (20mg/ml) Customer Service number (1-800-325-8888) - increased demand due to another manufacturer leaving the market read more

Drug Shortages - read more

Oplinc Newsletter - CORRECTION - CORRECTED EFFECTIVE DATE FOR CLINICAL PHARMACOLOGY COMPENDIA this week's Oplinc Fast Facts should have identified the effective date of July 2, 2008 for the Clinical Pharmacology Compendia. Please disregad the earlier issue and reference this corrected one. read more

FDA MedWatch - Tarceva - OSI, Genentech and FDA notified healthcare professionals of new safety information added to the WARNINGS AND PRECAUTIONS sections of the prescribing information for Tarceva. Gastrointestinal perforation (including fatalities), bullous, blistering and exfoliative skin conditions including cases suggestive of Stevens-Johnson syndrome/toxic epidermal necrolysis, in some cases fatal, and ocular disorders, including corneal perforation or ulceration have been reported during use of Tarceva.

Related Website: http://www.fda.gov/medwatch/safety/2009/safety09.htm#Tarceva

Avastin for Glioblastoma - FDA Approves Drug for Treatment of Aggressive Brain Cancer The U.S. Food and Drug Administration recently approved Avastin (bevacizumab) to treat patients with glioblastoma multiforme (GBM) when this form of brain cancer continues to progress following standard therapy. read more

Health Reform Dialogue - read more

U.S. Food and Drug Administration today approved Afinitor - FDA Approves Drug for an Advanced Form of Kidney Cancer The U.S. Food and Drug Administration today approved Afinitor oral tablets (everolimus) for the treatment of patients with advanced kidney cancer whose disease has progressed after treatment with other cancer therapies. Renal cell cancer, the most common type of kidney cancer, originates in the lining of the small tubules in the kidney that filter waste products from the blood. The cancer is resistant to such standard treatments as radiation therapy and chemotherapy, and the initial treatment for most patients is surgical removal of the kidney. If the cancer is confined to the kidney, the five-year survival rate is 60 to 70 percent; but the survival rate is considerably lower after the cancer has spread to other parts of the body. "Afinitor provides an option for patients with advanced renal cell cancer after failure of treatment with the cancer therapies sunitinib or sorafenib," said Robert Justice, M.D., director, Division of Drug Oncology Products in the FDA's Center for Drug Evaluation and Research. "Targeted cancer therapies like Afinitor have increased the number of months patients can live without the tumor progressing." Afinitor belongs to a class of drugs called kinase inhibitors, which interfere with cell communication, preventing tumor growth. The drug is intended for those patients with advanced renal cell cancer who have already tried another kinase inhibitor, Sutent (sunitinib) or Nexavar (sorafenib). While Sutent and Nexavar are multiple kinase inhibitors (acting on a number of cellular targets), Afinitor works by blocking a specific protein known as the mammalian target of rapamycin or mTOR. The protein blocking action disrupts the growth, division and metabolism of cancer cells. A clinical trial studying the safety and effectiveness of Afinitor was discontinued after an interim analysis showed that, in patients receiving the drug, the growth or spread of the tumor was delayed when compared to patients who did not receive the drug. In addition, disease progression was delayed approximately five months in half of the patients who received Afinitor. In contrast, disease progression was delayed two months in patients who did not receive the drug. The most frequent adverse reactions in the trial (occurring in at least 20 percent of patients) included inflammation in the mouth, loss of strength, diarrhea, poor appetite, fluid buildup in the extremities, shortness of breath, coughing, nausea, vomiting, rash, and fever. Laboratory tests of blood samples determined that at least half of all patients experienced anemia, low white blood counts, high cholesterol and high triglycerides and high blood sugar. Afinitor is manufactured by Novartis International AG of Basel, Switzerland. Sutent is manufactured by Pfizer Inc. of New York. Nexavar is manufactured by Bayer HealthCare AG, Leverkusen, Germany.

Related Website: http://www.fda.gov/bbs/topics/NEWS/2009/NEW01980.html

New Fact Sheet: Peanut Product Recall and Cancer Patients - New Fact Sheet: Peanut Product Recall and Cancer Patients The Centers for Disease Control and Prevention (CDC) has been receiving reports of illnesses caused by a type of bacterium known as Salmonella enterica, strain Typhimurium. The U.S. Food and Drug Administration (FDA) has confirmed that peanut butter and peanut paste produced by the Peanut Corporation of America (PCA) are sources of the illnesses. Due to this contamination, all peanut products produced by PCA on or after January 1, 2007 have been recalled. Because cancer patients with impaired immune systems are more likely to become severely ill from a Salmonella infection than others, the National Cancer Institute (NCI) developed a new Fact Sheet, Peanut Product Recall and Cancer Patients, to address the special concerns of cancer patients and their healthcare providers. • View NCI's Peanut Product Recall and Cancer Patients Fact Sheet: http://www.cancer.gov/cancertopics/factsheet/Support/peanut-recall • For a searchable list of recalled products, visit the FDA Web site: http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm For more additional information about this and other cancer-related topics, please visit the NCI Web site at http://www.cancer.gov or call NCI's Cancer Information Service at 1-800-4-CANCER (1-800-422-6237).