If your organization Persisted access using your organization’s identifier stored in your user browser for 90 days. Final gross price and currency may vary according to local VAT and billing address. Serious adverse reactions that occurred in more than 5% of patients who received Sarclisa combination therapy included pneumonia (25.3%) and febrile neutropenia (12.3%). Multiple myeloma epidemiology and survival: A unique malignancy. You need to be a logged in subscriber to view this content. Sarclisa (isatuximab-irfc) is a CD38-directed cytolytic antibody indicated in combination Sarclisa offers an intravenous (IV) administration and is dosed at 10 mg/kg, in combination with pom-dex, every week for four weeks and then every two weeks, until disease progression or unacceptable toxicity. Refractory multiple myeloma refers to cancer that does not respond to therapy. The U.S. list price (wholesale acquisition cost, or WAC) for Sarclisa is $650 per 100 mg vial and $3,250 per 500 mg vial. Sarclisa is expected to be available to patients in the U.S. shortly. FDA approves Sarclisa® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Available at: www.seer.cancer.gov/statfacts/html/mulmy.html. CD38 is highly and uniformly expressed on multiple myeloma cells and cell surface receptors, making it a potential target for antibody-based therapeutics such as Sarclisa. FDA to review isatuximab as a potential treatment for relapsed/refractory multiple myeloma. The safety and efficacy of Sarclisa has not been fully evaluated by any regulatory authority outside of the U.S. Sarclisa continues to be evaluated in multiple ongoing Phase 3 clinical trials in combination with current standard treatments for people with relapsed refractory or newly diagnosed multiple myeloma. Multiple Myeloma Leads to Significant Disease Burden. does not have a subscription 2016;43(6):676-681. doi:10.1053/j/seminoncol.2016.11.004. Sarclisa is a monoclonal antibody that binds to the CD38 receptor on multiple myeloma cells. These are patients whose disease has returned or become resistant to their prior treatments,” said Paul Hudson, Chief Executive Officer, Sanofi. This information will allow us to better understand how AdisInsight is being used. Sarclisa is a monoclonal antibody (mAb) that binds to the CD38 receptor on multiple myeloma cells. Sarclisa combination therapy also demonstrated a significantly greater overall response rate compared to pom-dex alone (60.4% vs. 35.3%, p<0.0001). Previous name: isatuximab “At Sanofi, we are focused on discovering and developing medicines that may change the practice of medicine, and Sarclisa offers a potential new standard of care in the United States. FDA approves Sarclisa ® (isatuximab-irfc) for patients with relapsed refractory multiple myeloma. It does not require or replace the individual login accounts that many of you use to save searches and create email alerts. Please enter your email address so we can determine if you need to complete a permission form or verify that you have already completed this form. If you opt-out your email will still be collected for registration purposes. How to enable JavaScript in your browser? That is why AdisInsight collects the minimum amount of information necessary to enable functionality, report usage, and contact you with information about AdisInsight. Sarclisa in combination with pomalidomide and dexamethasone (pom-dex) significantly reduced the risk of disease progression or death by 40% compared to pom-dex alone in a pivotal trial 2  National Cancer Institute. Unsubscription is always possible via email. Select one or more newsletters to continue. Multiple myeloma is the second most common hematologic malignancy,1 affecting more than 130,000 patients in the United States; approximately 32,000 Americans2 are diagnosed with multiple myeloma each year. A treatment cycle is 28 days. Since multiple myeloma does not have a cure, most patients will relapse at some point. Sarclisa (isatuximab-irfc) Consumer Information. Sarclisa has Orphan Drug Designation status from the FDA and the European Medicines Agency (EMA). Isatuximab is a humanised IgG1 monoclonal antibody developed by Sanofi, under a license from Immunogen, for the treatment of haematological malignancies and The first cycle is administered in an infusion time of 200 minutes, which can decrease to 75 minutes for the third cycle onwards. You have the right to opt-out of sharing your email address with your organization but doing so may negatively affect your organization’s decision to renew their subscription to AdisInsight. In the second quarter of 2019, the EMA accepted for review the Marketing Authorization Application for use of Sarclisa in combination with pom-dex for the treatment of certain patients with RRMM. For a typical patient in the U.S., between 70-80 kg (154-176 lbs), this correlates to a cost of $5,200 per infusion. Privacy Policy, Disclaimer, General Terms & Conditions. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Company: Sanofi Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. Your purchase entitles you to full access to the information contained in our drug profile at the time of purchase.

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