Vesanoid Reviewed By FDA Committee

Hoffmann-La Roche's new anticancer agent Vesanoid (all-trans-retinoic acid) has been recommended for approval by the US Food and Drug Administration's Oncologic Drugs Advisory Committee. The company is seeking to market the drug for the treatment of patients with acute promyelocytic leukemia. Specifically, Vesanoid will be used to induce remission in patients who are resistant to or who are contraindicated for anthracycline-based chemotherapy, or who have relapsed after entering remission induced by chemotherapy.

Vesanoid, which is designated an orphan drug in the USA, is administered orally in gelatin capsules until complete remission is achieved or the maximum treatment period of 90 days. It is a major advance for sufferers of APL, who currently have few treatment options.