Schering-Plough's Intron A (interferon alpha 2b) has been recommended for approval in the USA for the treatment of a new indication, malignant melanoma. The drug is already approved there for hairy cell leukemia, AIDS-related Kaposi's sarcoma, chronic hepatitis B and C and condylomata acuminata (venereal warts).
Data presented by the company to the Food and Drug Administration panel suggested that adding Intron A to existing treatment provided an increase in survival of one year, and a nine-month increase in relapse-free survival. If the FDA goes along with the advisory panel's verdict, Intron A would be indicated as an adjuvant treatment to surgery in patients with malignant melanoma who are free of disease but who are at high risk of systemic recurrence.
The data from the study, which was conducted by the Eastern Cooperative Oncology Group, revealed an overall median survival of 3.8 years for the Intron A group compared to 2.8 years for an observation-only group. The median relapse-free survival times were 1.7 years and one year, respectively. Both of these results were statistically significant. In addition, Intron A increased five-year survival by 31% and five-year relapse-free survival by 54%.
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