Blenoxane Cleared for New Use In Malignant Pleural Effusion

PRINCETON, NJ--Blenoxane (bleomycin), Bristol-Myers Squibb Co.'santicancer agent, has received FDA clearance for a new indicationas intrapleural therapy for the relief of symptoms resulting frommalignant pleural effusion (MPE) and prevention of recurrent pleuraleffusions.

Blenoxane is the first sclerosing agent to be approved for treatmentof MPE, a significant complication of a number of primary malignancies.

The FDA decision was based on a literature-based supplementalNew Drug Application (NDA), submitted in 1993. This is the firstliterature-based supplemental NDA to be approved since the FDAbegan accepting this type of submission, the company said.

The Blenoxane application referenced safety and effectivenessdata from more than 70 books, articles, and published papers describingthe use of the product as an option for the treatment of MPE,including reports of seven well-controlled, randomized trials.