Blenoxane Cleared for New Use In Malignant Pleural Effusion

Publication
Article
Oncology NEWS InternationalOncology NEWS International Vol 5 No 5
Volume 5
Issue 5

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.

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.

Recent Videos
Future findings from a translational analysis of the OVATION-2 trial may corroborate prior clinical data with IMNN-001 in advanced ovarian cancer.
The dual high-affinity binding observed with ISB 2001 may avoid resistance mechanisms reported with other BCMA-targeted therapies.
The use of chemotherapy trended towards improved recurrence-free intervals in older patients with high-risk tumors as determined via the MammaPrint assay.
Use of a pharmacist-directed resource appears to improve provider confidence and adverse effect monitoring for patients undergoing infusion therapy.
Reshma L. Mahtani, DO, describes how updates from the DESTINY-Breast09, ASCENT-04, and VERITAC-2 trials may shift practices in the breast cancer field.
2 experts in this video
Related Content