Policy & Regulation
Sanofi's isatuximab biologics license application accepted for US FDA review
12 July 2019 -

France-based Sanofi's biologics license application for isatuximab has been accepted for review by the US Food and Drug Administration (FDA), it was reported yesterday.

The product has been designed to target a specific epitope on the CD38 receptor of a plasma cell. It is intended to activate multiple, distinct mechanisms of action that are thought to directly encourage programmed tumour cell death (apoptosis) and immunomodulatory activity. It is regarded as a highly and uniformly expressed on various myeloma cells. It is a cell surface receptor target for antibody-based treatments in multiple myeloma and other malignancies.

The company's biologics license application for the monoclonal antibody is concentrated on positive data from ICARIA-MM, an open-label phase three trial in patients with relapsed/refractory multiple myeloma. The late-stage trial that featured 307 patients has met the primary endpoint of prolonging progression free survival in patients treated with the investigational drug in combination with pomalidomide and low-dose dexamethasone.

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