BioCentury
ARTICLE | Clinical News

Balugrastim: Phase III data

July 9, 2012 7:00 AM UTC

A double-blind Phase III trial in 304 breast cancer patients receiving chemotherapy showed that subcutaneous injections of 40 mg balugrastim was non-inferior to subcutaneous injections of 6 mg Neulasta pegfilgrastim on the primary endpoint of reducing the mean duration of severe chemotherapy-induced neutropenia in cycle 1 of treatment (1.1 vs. 1 day). Balugrastim was also non-inferior to Neulasta on the secondary endpoint of the proportion of patients who experienced severe neutropenia in cycle 1 (58% vs. 59%). Rates of treatment-related adverse events were 20% and 19%, respectively. Data were presented at the Multinational Association of Supportive Care in Cancer/International Society of Oral Oncology meeting on Supportive Care in Cancer in New York. ...