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.