Date: 2012-06-29
Type of information:
phase: 3
Announcement: presentation of clinical results for balugrastim, at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2012 International Symposium on Supportive Care in Cancer being held in New York June 28-30.
Company: Teva Pharmaceutical Industries (Israel)
Product: balugrastim (recombinant G-CSF fused to human albumin)
Action
mechanism: Balugrastim is a long-acting G-CSF using the albumin-fusion technology initially developed by Human Genome Sciences to prolong plasma half-life. Balugrastim is designed to provide clinical efficacy and safety profiles which are fully comparable to Neulasta®.
Disease: reduction in the duration of severe neutropenia in breast cancer patients undergoing chemotherapy
Therapeutic area: Cancer - Oncology
Country:
Trial details:
Latest
news: Teva Pharmaceutical Industries has announced the presentation of clinical results for its biologic oncology candidate balugrastim, at the Multinational Association of Supportive Care in Cancer (MASCC)/International Society of Oral Oncology (ISOO) 2012 International Symposium on Supportive Care in Cancer being held in New York June 28-30.
The product candidate has completed phase III clinical trial. In this phase III breast cancer study the primary endpoint was achieved, demonstrating reduction in the duration of severe neutropenia (DSN) in cycle 1, comparable to pegfilgrastim results in both efficacy and safety measures.
Teva expects to submit balugrastim for registration in the United States and in Europe in 2012.
