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                Resources for Information | Approved Drugs

Resources for Information | Approved Drugs

                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
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          FDA D.I.S.C.O. Burst Edition: FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapyResources for Information | Approved Drugs FDA D.I.S.C.O. Burst Edition: FDA approval of Sarclisa (isatuximab-irfc) in combination with carfilzomib and dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy
  
  	
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Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll be providing another quick update on a recent FDA cancer drug approval.

On March 31, 2021, the FDA approved isatuximab-irfc (brand name Sarclisa) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy.

The efficacy and safety of isatuximab in combination with carfilzomib and dexamethasone was evaluated in IKEMA, a multicenter, multinational, randomized, open-label, two-arm, phase 3 trial in patients with relapsed and/or refractory multiple myeloma who had received one to three prior lines of therapy. A total of 302 patients were randomized in a 3:2 ratio to receive isatuximab with carfilzomib and dexamethasone or carfilzomib and dexamethasone alone. The main efficacy outcome measure was progression-free survival, assessed by an independent response committee based on central laboratory data for M-protein and central radiologic imaging review using International Myeloma Working Group criteria. Median progression-free survival was not reached in the isatuximab with carfilzomib and dexamethasone arm and was 20.27 months in the carfilzomib and dexamethasone arm. This represented a 45% reduction in the risk of disease progression or death in patients treated with isatuximab with carfilzomib and dexamethasone compared to those treated with carfilzomib and dexamethasone alone.

The most common adverse reactions reported in more than 20% of patients receiving isatuximab with carfilzomib and dexamethasone were upper respiratory tract infection, infusion-related reactions, fatigue, hypertension, diarrhea, pneumonia, dyspnea, insomnia, bronchitis, cough, and back pain. The most common hematologic laboratory abnormalities occurring in more than 80% of patients were decreased hemoglobin, decreased lymphocytes, and decreased platelets.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment. The FDA approved this application 3 months ahead of the FDA goal date.

Full prescribing information for this approval can be found on the web at www.fda.gov/drugsatFDA.

Health care professionals should report serious adverse events to FDA’s MedWatch Reporting System at www.fda.gov/medwatch.

Follow the Division of Drug Information on Twitter @FDA_Drug_Info and the Oncology Center of Excellence @FDAOncology. Send your feedback via email to FDAOncology@fda.hhs.gov.

                                                                                  Content current as of:
      04/13/2021Resources for Information | Approved Drugs

          
                        Oncology (Cancer) / Hematologic Malignancies Approval Notifications
          Ongoing | Cancer Accelerated Approvals
          Verified Clinical Benefit | Cancer Accelerated Approvals
          Withdrawn | Cancer Accelerated Approvals
          Other | Cancer Accelerated Approvals


                        Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) Short Description
 
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