Sanofi Reports FDA’s Acceptance of BLA to Review Isatuximab for Relapsed/Refractory Multiple Myeloma

Sanofi Reports FDA’s Acceptance of BLA to Review Isatuximab for Relapsed/Refractory Multiple Myeloma Sanofi Reports FDA’s Acceptance of BLA to Review Isatuximab for Relapsed/Refractory Multiple Myeloma

Shots:

  • The BLA is based on P-III ICARIA-MM study results assessing Isatuximab in combination with pomalidomide and dexamethasone in patients with RRMM, presented at ASCO2019 and EHA 2019
  • Isatuximab has received the US FDA and EMA’s ODD designation for RRMM and the EMA has accepted its MAA in Q2’19 with its expected FDA’s PDUFA date as April 30, 2020
  • Isatuximab is a mAb targeting the CD38 receptor of a plasma cell, being evaluated in P-III studies in combination with SOC for r/r or newly diagnosed multiple myeloma, also investigated for hematologic malignancies and solid tumors

Click here to read full press release/ article | Ref: Sanofi | Image: China daily