PRINCETON, NJ--Blenoxane (bleomycin), Bristol-Myers Squibb Co.'s anticancer agent, has received FDA clearance for a new indication as intrapleural therapy for the relief of symptoms resulting from malignant pleural effusion (MPE) and prevention of recurrent pleural effusions.
Blenoxane is the first sclerosing agent to be approved for treatment of MPE, a significant complication of a number of primary malignancies.
The FDA decision was based on a literature-based supplemental New Drug Application (NDA), submitted in 1993. This is the first literature-based supplemental NDA to be approved since the FDA began accepting this type of submission, the company said.
The Blenoxane application referenced safety and effectiveness data from more than 70 books, articles, and published papers describing the use of the product as an option for the treatment of MPE, including reports of seven well-controlled, randomized trials.