'Intron A' Receives FDA Indication for High-Risk Melanoma

MADISON, NJ--Schering-Plough Corporation's Intron A for Injection(interferon alfa-2b, recombinant) has received FDA clearance fora new indication as adjuvant treatment to surgery in malignantmelanoma patients at high risk for systemic recurrence.

Intron A is the first adjuvant therapy to surgery in malignantmelanoma that has been shown to significantly increase relapse-freeand overall survival, the company said. The product has previouslyreceived FDA approval for treatment of hairy cell leukemia, AIDS-relatedKaposi's sarcoma, condylomata acuminata, and chronic hepatitisB and C.

In a multicenter, randomized, controlled phase III study fromthe Eastern Cooperative Oncology Group (E1684) of 280 malignantmelanoma patients, the addition of Intron A after surgical removalof the tumor increased median overall survival by more than 12months (45.8 months for the patients who received adjuvant IntronA therapy vs 33.4 months for the observation only patient group).

Median relapse-free survival was increased by 9 months with useof Intron A (20.6 months for adjuvant therapy patients vs 11.8months for controls).

The adjuvant therapy resulted in a 24% improvement in 5-year overallsurvival (46% vs 37% of controls) and a 42% improvement in 5-yearrelapse-free survival (37% vs 26% of controls).

The most common side effects of Intron A were fatigue or flu-likesymptoms. With dose modifications and proper patient managementtechniques, the company said, 74% of the Intron A patients wereable to tolerate a full course of therapy, defined as 52 weeksor until disease progression.