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
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.