FDA Panel Backs New Use For Intron A

The US Food and Drug Administration's Biological Response ModifiersAdvisory Committee has voted unanimously in support of a new indication for Schering-Plough's Intron A (interferon alfa-2b) - the first-line adjunctive treatment of advanced non-Hodgkin's lymphoma.

Intron A did not improve overall survival in patients with low-grade, rapidly-progressing NHL, but did delay disease progression, the panelists concluded. As the drug is associated with significant side effects, including immunosuppression, weakness, fatigue, fever and liver enzyme elevations, they also voted unanimously that Intron A should not be approved for less advanced NHL

In a statement, S-P said it was looking forward to an expedited review of the labeling by the FDA. The data presented at the meeting suggested that addition of Intron A to a standard chemotherapy regimen (cyclophosphamide, doxorubicin, teniposide and prednisone) improved the time to disease progression from 18 months to three years. Response rates were 90% for the Intron A group and 74% for those taking chemotherapy alone.