Chiron Submits BLA For Proleukin

Chiron Corp has submitted a supplemental Biological License Applicationto the US Food and Drug Administration, seeking to market its immunotherapeutic agent Proleukin (aldesleukin, recombinant interleukin-2 for injection), for the treatment of patients with metastatic melanoma.

Data from a 270-patient trial demonstrate that IL-2 as a single agent can produce a long duration of response; some patients remained disease-free for eight years plus. The normal median survival time for late-stage melanoma patients is about seven months. The company reports that the toxic effects of Proleukin were severe, but were reversible in the main, and rarely chronic.

Proleukin is currently marketed for the treatment of metastatic renal cell carcinoma, but received Orphan Drug Status for the metastatic melanoma indication last year. The company is also supporting studies using IL-2 in combination with chemotherapy and alpha interferon for the treatment of metastatic melanoma, and is investigating IL-2's use in a range of other cancers, including non-Hodgkin's lymphoma and acute myelogenous leukemia.