Press Release: Sanofi's SAR446523, a GPRC5D monoclonal antibody, earns orphan drug designation in the US for multiple myeloma

Core Viewpoint - Sanofi's SAR446523, a GPRC5D monoclonal antibody, has received orphan drug designation from the FDA for the treatment of relapsed or refractory multiple myeloma, highlighting the company's commitment to developing innovative therapies for this rare disease [1][2]. Group 1: Product Information - SAR446523 is an investigational IgG1-based monoclonal antibody designed to target GPRC5D, which is highly expressed on plasma cells, and aims to enhance antibody-dependent cell-mediated cytotoxicity [3]. - The drug is currently undergoing a phase 1 clinical study in patients with relapsed or refractory multiple myeloma, with the clinical study identifier NCT06630806 [3]. Group 2: Disease Context - Multiple myeloma is the second most common hematologic malignancy, with over 180,000 new diagnoses globally each year, yet it remains incurable with a five-year survival rate of approximately 62% for newly diagnosed patients [4]. - There is a significant need for new therapeutic options, particularly for patients who are ineligible for transplants, due to high attrition rates in subsequent lines of therapy [4]. Group 3: Company Commitment - Sanofi is dedicated to advancing oncology treatments and aims to transform cancer care through innovative therapies for rare and difficult-to-treat cancers [5]. - The company emphasizes its long-standing commitment to oncology and the development of first and best-in-class immunological and targeted therapies [5][6].