The mm Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the mm Hub cannot guarantee the accuracy of translated content. The mm and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.
The Multiple Myeloma Hub is an independent medical education platform, sponsored by Bristol Myers Squibb, GSK, Johnson & Johnson, Pfizer, Roche and Sanofi. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View mm content recommended for you
FDA approves isatuximab plus pomalidomide and dexamethasone for the treatment of relapsed or refractory multiple myeloma
Featured:
On March 2, 2020, isatuximab-irfc in combination with pomalidomide and dexamethasone (pom-dex) was granted approval by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor.1,2 Isatuximab is a monoclonal antibody against CD38, which is highly expressed on the surface of multiple myeloma cells. Upon binding to a malignant cell, the antibody induces apoptosis and has immunomodulatory activity, leading to inhibition of cancer growth.3
The approval was based on the positive results of the phase III ICARIA-MM clinical trial, which demonstrated improved overall response rate (ORR) and progression free survival (PFS) with isatuximab plus pom-dex compared to pom-dex alone (ORR 60.4% vs 35.3%, p < 0.0001; median PFS 11.53 months vs 6.47 months, HR 0.596, 95% CI, 0.44–0.81, p = 0.0010).2 You can watch Paul G. Richardson from the Dana-Farber Cancer Institute, Boston, US, discussing the results here or read about the results from a subgroup analysis by patient cytogenetics.
The most common adverse reactions of any grade, reported by more than 20% of patients, were neutropenia (96%), infusion-related reactions (39%), pneumonia (31%), upper respiratory tract infection (57%), and diarrhea (26%). Serious adverse reactions occurring in more than 5% of patients included pneumonia and febrile neutropenia, which were reported in 25.3% and 12.3% of patients, respectively.2
Isatuximab has previously been granted Orphan Drug Designation by the FDA and the European Medicines Agency (EMA). Phase III clinical trials evaluating isatuximab in other combinations for patients with relapsed, refractory, or newly diagnosed multiple myeloma are still ongoing. Efficacy and safety of the antibody for the treatment of other hematologic malignancies and solid tumors is also being evaluated.2
Expert Opinion
Paul RichardsonReferences
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content