Product Description
Isatuximab-irfc injection is used along with pomalidomide (Pomalyst) and dexamethasone to treat multiple myeloma (a type of cancer of the bone marrow) in adults who have received at least two other medications, including lenalidomide (Revlimid) and a proteasome inhibitor such as bortezomib (Velcade) or carfilzomib (Kyprolis). It is also used along with carfilzomib (Kyprolis) and dexamethasone to treat multiple myeloma in adults whose cancer has returned or is unresponsive to at least one other treatment. Isatuximab-irfc injection is in a class of medications called monoclonal antibodies. It works by helping the body to slow or stop the growth of cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a620023.html)
Mechanisms of Action: CD38 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Priority Review - Multiple Myeloma *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Croatia | Cyprus | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: Multiple Myeloma
Known Adverse Events: Anemia | Lymphopenia | Thrombocytopenia | Neutropenia | Respiratory Tract Infections | Pneumonia | Diarrhea
Company: Sanofi
Company Location: PARIS I0 75008
Company CEO: Paul Hudson
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Russia, Serbia, South Korea, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 84
Highest Development Phases
Phase 3: Multiple Myeloma|Stem Cell Transplant|Tobacco Use Disorder
Phase 2: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Amyloidosis|Anemia, Hemolytic, Autoimmune|Anemia, Refractory|Blood Protein Disorders|Cryoglobulinemia|Glioblastoma|Head and Neck Cancer|Hepatocellular Carcinoma|Kidney Diseases|Leukemia, Plasma Cell|Leukopenia|Lymphoid Leukemia|Lymphoma, Non-Hodgkin|Monoclonal Gammopathy of Undetermined Significance|Ovarian Cancer|Paraproteinemias|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|Purpura, Thrombocytopenic, Idiopathic|Squamous Cell Carcinoma|T-Cell Leukemia|T-Cell Lymphoma|Thrombocytopenia|Transitional Cell Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| EFC15992 | P3 |
Unknown Status |
Multiple Myeloma |
2034-05-30 |
|
| jRCT2031210017 | P3 |
Active, not recruiting |
Multiple Myeloma |
2033-08-31 |
|
| 2019-003139-47 | P3 |
Active, not recruiting |
Multiple Myeloma |
2033-04-30 |
|
| EFC15992 | P3 |
Active, not recruiting |
Multiple Myeloma |
2030-10-14 |