MADISON, NJ--Schering-Plough Corporation's Intron A for Injection (interferon alfa-2b, recombinant) has received FDA clearance for a new indication as adjuvant treatment to surgery in malignant melanoma patients at high risk for systemic recurrence.
Intron A is the first adjuvant therapy to surgery in malignant melanoma that has been shown to significantly increase relapse-free and overall survival, the company said. The product has previously received FDA approval for treatment of hairy cell leukemia, AIDS-related Kaposi's sarcoma, condylomata acuminata, and chronic hepatitis B and C.
In a multicenter, randomized, controlled phase III study from the Eastern Cooperative Oncology Group (E1684) of 280 malignant melanoma patients, the addition of Intron A after surgical removal of the tumor increased median overall survival by more than 12 months (45.8 months for the patients who received adjuvant Intron A therapy vs 33.4 months for the observation only patient group).
Median relapse-free survival was increased by 9 months with use of Intron A (20.6 months for adjuvant therapy patients vs 11.8 months for controls).
The adjuvant therapy resulted in a 24% improvement in 5-year overall survival (46% vs 37% of controls) and a 42% improvement in 5-year relapse-free survival (37% vs 26% of controls).
The most common side effects of Intron A were fatigue or flu-like symptoms. With dose modifications and proper patient management techniques, the company said, 74% of the Intron A patients were able to tolerate a full course of therapy, defined as 52 weeks or until disease progression.