Sanofi said that its biologics license application (BLA) for isatuximab for the treatment of relapsed/refractory multiple myeloma (RRMM) has been accepted for review by the US Food and Drug Administration (FDA).
An investigational monoclonal antibody, isatuximab, has been designed to target a specific epitope on the CD38 receptor of a plasma cell. The drug has been designed to activate multiple, distinct mechanisms of action that are thought to directly encourage programmed tumour cell death (apoptosis) and immunomodulatory activity.
CD38 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 FDA has set a target action date of 30 April 2020 to take a decision on isatuximab’s approval.
Sanofi’s BLA for the monoclonal antibody is centred on positive data from ICARIA-MM, an open-label phase 3 trial in patients with RRMM. The late-stage trial, which featured 307 patients, met the primary endpoint of prolonging progression free survival in patients treated with the investigational drug in combination with pomalidomide and low-dose dexamethasone.
The ICARIA-MM trial compared the investigational combination against pomalidomide and low-dose dexamethasone alone, which is the standard of care for the hematologic malignancy.
The FDA and the European Medicines Agency (EMA) had granted orphan designation to isatuximab for RRMM. In the second quarter of this year, the EMA accepted for review the marketing authorization application of the investigational drug.
Currently, isatuximab is being evaluated in various phase 3 trials in combination with current standard treatments for people having relapsed/refractory or newly-diagnosed multiple myeloma. The monoclonal antibody is also being investigated for the treatment of other hematologic malignancies and solid tumours.
Earlier this month, Sanofi alongside Regeneron Pharmaceuticals has been given conditional approval by the European Commission (EC) for Libtayo (cemiplimab) for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma (CSCC) in adults.
Libtayo is a fully-human monoclonal antibody, which targets the immune checkpoint receptor PD-1 (programmed cell death protein-1). According to Sanofi, Libtayo is the only treatment to be approved in advanced CSCC in the European Union (EU).