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Bristol-Myers Squibb’s Blenoxane (bleomycin)

Executive Summary

Company files literature-based supplemental NDA on June 11 for the palliative treatment of malignant pleural effusion. The application consists of safety and effectiveness data from "more than 70 books, articles and published papers," BMS announces June 24. Currently, there is no FDA-approved drug for MPE. The firm says it undertook the supplemental submission in response to FDA's public comments encouraging the use of literature reviews to support approval of off-label uses. Blenoxane is approved for palliative treatment of squamous cell carcinoma, lymphomas and testicular carcinoma.
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PS022836

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