Schering-Plough’s Antifungal Agent Noxafil Oral Suspension Receives Category 1 Recommendation

Schering-Plough Corporation (NYSE: SGP) today reported that its antifungal agent NOXAFIL(R) (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.”