Intron A (interferon alfa-2b, recombinant) for injection in conjunction with anthracycline-containing combination chemotherapy has been approved for the initial treatment of patients with clinically aggressive non-Hodgkin's lymphoma (NHL). This represents approval of a new indication for Intron A. In addition to NHL, Intron A has received marketing clearance in the U.S. for the treatment of chronic hepatitis B, chronic hepatitis C, hairy cell leukemia, AIDS related Kaposi's sarcoma, condylomata acuminata (venereal warts), and as adjuvant therapy for malignant melanoma.
Intron A is the first and only biologic agent that has been shown to significantly prolong progression-free survival in previously untreated patients with follicular lymphoma.
In a clinical study conducted by Groupe d'Etude des Lymphomes Folliculares (GELF), the addition of Intron A to chemotherapy increased median progression-free survival from 1.5 years in patients with chemotherapy alone to 2.9 years in patients in the chemotherapy plus Intron A group. Moreover, patients in the chemotherapy + Intron A group experienced a significant prolongation of overall survival as compared to patients in the chemotherapy alone group (median not yet reached vs. 5.6 years).
Side effects reported in association with Intron A plus chemotherapy were as expected and controllable through dose modifications. The most common side effects were flu-like symptoms, vomiting, nausea, anorexia, abdominal pain, diarrhea, and alopecia.