Bristol-Myers Squibb’s Blenoxane

Executive Summary

FDA's Oncologic Drugs Advisory Committee on Sept. 23 will review a BMS supplemental NDA (50-443) for bleomycin sulfate as a sclerosing agent for the treatment of malignant pleural effusions (MPE) and for the prevention of recurrent pleural effusions. There currently is no approved therapy for MPE. The SNDA is literature- based and was filed by the company on June 11 ("The Pink Sheet" June 28, In Brief). Blenoxane currently is approved for the palliative treatment of squamous cell carcinoma, lymphomas and testicular carcinoma.