Healthcare Industry News: myelodysplastic syndromes
News Release - March 20, 2007
New Cancer Practice Guidelines Recommend NOXAFIL(R) (Posaconazole) for Antifungal Prophylaxis in Certain High-Risk PatientsKENILWORTH, N.J., March 20 (HSMN NewsFeed) -- Schering-Plough Corporation (NYSE: SGP ) today reported that its antifungal agent NOXAFILŽ (posaconazole) Oral Suspension received a category 1 recommendation(1) (highest rating) for preventing certain invasive fungal infections (IFIs) in high-risk cancer patients in the latest National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Prevention and Treatment of Infections in Patients with Cancer. The recommendation pertains to NOXAFIL's approved indication for IFI prophylaxis of neutropenic patients with myelodysplastic syndromes (MDS) or acute myelogenous leukemia (AML), and hematopoietic stem cell transplant (HSCT) recipients with significant graft- versus-host disease GVHD. NOXAFIL also received a category 2B recommendation(2) for preventing IFIs in neutropenic cancer patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT), a high- risk population not studied in the NOXAFIL registration trials.
The NCCN Clinical Practice Guidelines in Oncology are the recognized standard for clinical practice in the oncology community. The updated guidelines were presented during the NCCN's 12th Annual Conference on Clinical Practice Guidelines and Quality Cancer Care, March 14-18, in Hollywood, Fla.
NCCN is an alliance of 20 leading U.S. cancer centers and an authoritative source of information to help both clinicians and patients make informed decisions about cancer care.
NOXAFIL was approved by the U.S. Food and Drug Administration (FDA) in September 2006 for prevention of invasive Aspergillus and Candida infections in patients 13 years of age and older who are at high risk of developing these infections due to being severely immunocompromised, such as HSCT recipients with GVHD or those with hematologic malignancies with prolonged neutropenia from chemotherapy. NOXAFIL is the first and only antifungal agent approved by FDA for the prevention of IFIs caused by both Aspergillus and Candida. Patients undergoing HSCT or chemotherapy for hematological malignancies who develop IFIs have a mortality rate ranging from 50-90 percent.(3)
"The inclusion of NOXAFIL in the revised NCCN clinical practice guidelines highlights the importance of antifungal prophylaxis as a key therapeutic strategy in the management of patients at high risk for invasive fungal infections, such as those undergoing chemotherapy for acute myelogenous leukemia or myelodysplastic syndromes, or stem cell transplantation," said Amelia Langston, M.D., associate professor of hematology and oncology, and medical director, Emory Bone Marrow and Stem Cell Transplant Center, Emory University Hospital, Atlanta. "These infections are being seen more frequently and are a leading cause of death in these seriously ill patients."
About the NCCN Guidelines
The NCCN guidelines are updated continually and are based on evaluation of scientific data integrated with expert judgment by multidisciplinary panels of expert physicians from NCCN Member Institutions. The breadth and scope of this collaborative effort, which now covers more than 97 percent of all cancers, represents a significant advance beyond any previously developed guidelines. The NCCN guidelines have become the most widely used in oncology practice. Treatment recommendations are specific and are implemented through performance measurement. In addition, the NCCN guideline panels address cancer detection, risk assessment and reduction, and supportive care areas such as nausea and vomiting, distress management, cancer-related fatigue, and cancer pain management.
The NCCN Clinical Practice Guidelines in Oncology can be found on its Web site at www.nccn.org. Development of the guidelines is supported by NCCN Member Institution dues. No industry support is accepted for any costs associated with the development of the guidelines.
NOXAFIL received marketing approval for prophylaxis of certain invasive fungal infections in the United States and European Union (EU) in 2006, based primarily on the results of two landmark clinical studies that were published recently in The New England Journal of Medicine.(4,5)
NOXAFIL also was approved in the United States and EU in 2006 for the treatment of oropharyngeal candidiasis (OPC), a fungal infection of the mouth and throat, and in the EU in 2005 and Australia in 2006 for the treatment of certain IFIs in adult patients with disease that is refractory to or in patients who are intolerant of certain commonly used antifungal agents. NOXAFIL is a novel triazole antifungal agent discovered and developed by Schering-Plough Research Institute.
NOXAFIL Safety Information
The most common treatment-related serious adverse events (1 percent each) in the combined NOXAFIL prophylaxis studies were bilirubinemia, increased hepatic enzymes, hepatocellular damage, nausea, and vomiting. In clinical trials, there were infrequent cases of hepatic reactions (e.g., mild to moderate elevations in ALT, AST, alkaline phosphatase, total bilirubin, and/or clinical hepatitis). Rarely, more severe hepatic reactions including cholestasis or hepatic failure including fatalities were reported in patients with serious underlying medical conditions (e.g., hematologic malignancies) during treatment with NOXAFIL. Liver function tests (LFTs) should be monitored at the start of and during the course of therapy.
In the pooled prophylaxis safety analysis, fever, headache, anemia, diarrhea, nausea, vomiting, abdominal pain, hypokalemia and thrombocytopenia were frequently reported treatment-emergent adverse events.
NOXAFIL has been shown to interact with several medications, including drugs that suppress the immune system, and these reactions may be serious. The product label should be consulted when other drugs are prescribed with NOXAFIL.
In clinical studies of oropharyngeal candidiasis (OPC) and refractory OPC, adverse events were reported more frequently in the pool of patients with refractory oropharyngeal candidiasis. The most commonly reported serious adverse events included fever (13 percent) and neutropenia (10 percent).
Co-administration with the CYP3A4 substrates terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine, is contraindicated since this may result in increased plasma concentrations of these medicinal products, leading to QTc prolongation and rare occurrences of torsades de pointes. Co- administration with ergot alkaloids is also contraindicated.
Serious and rare fatal toxicity from cyclosporine has occurred when taken in combination with NOXAFIL and therefore reduction of the dose of drugs like cyclosporine, tacrolimus, or sirolimus and frequent monitoring of drug levels of these medications is necessary when taking them in combination with NOXAFIL.
The safety and effectiveness of NOXAFIL in patients below the age of 13 years old have not been established. In the EU, NOXAFIL is recommended for use in patients 18 years of age and older.
For NOXAFIL U.S. Prescribing Information please visit: http://www.spfiles.com/pinoxafil.pdf.
Schering-Plough is a global science-based health care company with leading prescription, consumer and animal health products. Through internal research and collaborations with partners, Schering-Plough discovers, develops, manufactures and markets advanced drug therapies to meet important medical needs. Schering-Plough's vision is to earn the trust of the physicians, patients and customers served by its approximately 33,500 people around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.
SCHERING-PLOUGH DISCLOSURE NOTICE: The information in this press release includes certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of NOXAFIL. Forward-looking statements relate to expectations or forecasts of future events. Schering-Plough does not assume the obligation to update any forward-looking statement. Many factors could cause actual results to differ materially from Schering-Plough's forward- looking statements, including market forces, economic factors, product availability, patent and other intellectual property protection, current and future branded, generic or over-the-counter competition, the regulatory process, and any developments following regulatory approval, among other uncertainties. For further details of these and other risks and uncertainties that may impact forward-looking statements, see Schering-Plough's Securities and Exchange Commission filings, including Part I, Item 1A, "Risk Factors" in the company's 2006 10-K.
(1) Category 1 recommendation: There is uniform NCCN consensus, based on high-level evidence, that the recommendation is appropriate.
(2) Category 2B recommendation: There is nonuniform NCCN consensus (but no major disagreement), based on lower-level evidence including clinical experience, that the recommendation is appropriate.
(3) Bow EJ, Laverdiere M, Lussier N, et al. Antifungal Prophylaxis for Severely Neutropenic Chemotherapy Recipients. Cancer 2002;94:3230-46.
(4) Ullmann AJ, Lipton JH, Vesole DH, et al. Posaconazole or Fluconazole for Prophylaxis in Severe Graft-versus-Host Disease. N Engl J Med 2007;356:335-47.
(5) Cornely OA, Maertens J, Winston DJ, et al. Posaconazole vs. Fluconazole or Itraconazole Prophylaxis in Patients with Neutropenia. N Engl J Med 2007;356:348-59.
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