ODAC Recommends Approval of Pegylated Interferon Alfa-2b for Malignant Melanoma

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OncologyONCOLOGY Vol 23 No 11
Volume 23
Issue 11

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for pegylated interferon alfa-2b (PegIntron) in the adjuvant treatment of patients with stage III malignant melanoma.

The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for pegylated interferon alfa-2b (PegIntron) in the adjuvant treatment of patients with stage III malignant melanoma.

Pegylated interferon alfa-2b is a longer-acting form of the protein interferon alfa-2b (Intron A). The drug is administered subcutaneously once-weekly via self-injection.

Schering-Plough filed the supplemental Biologics License Application (sBLA) for this indication to the FDA in September 2007.

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Surgical Removal of Primary Tumor Improves Survival in Metastatic Breast Cancer Patients
Survival Benefit Maintained in Long-Term Follow-up of Intergroup Exemestane Study
Neoadjuvant Capecitabine Added to Standard Treatment Helps to Eradicate Tumors in Patients
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The Allegheny General Modification of the Harvard Breast Cosmesis Scale for the Retreated Breast
Managing a Small Recurrence in the Previously Irradiated Breast
Sorafenib Plus Chemotherapy Significantly Prolongs Progression-Free Survival in Advanced Breast Cancer
Pralatrexate Approved for Relapsed or Refractory Peripheral T-cell Lymphoma
FDA Clears OVA1 Test to Determine Ovarian Cancer Risk in Women With Pelvic Mass
MammoSite ML Radiation Therapy System Cleared for Treating Early-Stage Breast Cancer
ODAC Recommends Approval of Pegylated Interferon Alfa-2b for Malignant Melanoma
Key Points in Repeat Breast-Conservation Therapy
Reirradiation of the Breast: Is This an Option?
Brachytherapy or Surgery? A Composite View
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Further Perspectives on Treating Localized Prostate Cancer
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