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Clinical Trials

Date: 2012-06-29

Type of information:

phase: 3

Announcement: presentation of clinical results for lipegfilgrastim 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: lipegfilgrastim

Action mechanism: Lipegfilgrastim is a glycopegylated, recombinant form of G-CSF. Pegylation extends the half-life of the drug so that less frequent dosing is required compared with nonpegylated G-CSF. It has been designed to stimulate the bone marrow to produce white blood cells to reduce the duration of severe neutropenia.
The product was added to the Teva`s portfolio through the acquisition of ratiopharm and is designed to provide clinical efficacy and safety profiles which are fully comparable to Neulasta®.


Disease: reduction of 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, lipegfilgrastim 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  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.


Is general: Yes