For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCEs Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov. To be eligible for inclusion in ICARIA-MM, adults with RRMM had to have measurable disease [M-protein 0.5 g/dL (serum) or 200 mg/24 h (urine)]; they also had to have received 2 prior lines of therapy, including lenalidomide and a PI, and to be refractory to their last line of therapy (i.e. 2021. Napumpujte ho antioxidantmi a vitamnmi! FOIA runny or stuffy nose. Rajkimar SV. Treatment-emergent adverse events (TEAEs) of any grade occurred in similar proportions of isatuximabpomalidomidedexamethasone and pomalidomidedexamethasone recipients in ICARIA-MM (99% vs 98%) (n = 152 and 149, respectively) [25], as well as isatuximabcarfilzomibdexamethasone and carfilzomibdexamethasone recipients in IKEMA (97% vs 96%) [n = 177 and 122, respectively] [29]. Demographic and disease characteristics at baseline were generally well balanced between the treatment groups [28]. Health-related quality of life in heavily pretreated and renally impaired patients with relapsed/refractory multiple myeloma receiving isatuximab plus pomalidomide and dexamethasone: ICARIA-MM study [abstract no. Tell any doctor who treats you that you are using isatuximab. Copyright 1996-2023 Cerner Multum, Inc. In vivo, isatuximab prolonged survival in a human MM xenograft model in immunocompromised mice [20]. What is isatuximab? Chari A, Richter JR, Shah N, et al. This medicine can affect the results of certain medical tests. 2019. Health-related quality of life (HRQOL), as assessed using the European Organization for Research and Treatment of Cancer Quality of Life questionnaire Core 30 (EORTC QLQ-C30), was preserved with the addition of isatuximab to pomalidomidedexamethasone [40]. The primary endpoint was PFS per IRC; key secondary endpoints were the ORR and VGPR per IRC, and OS. Before using isatuximab tell your doctor about all your medical conditions or allergies, all medicines you use, and if you are pregnant or breastfeeding. Brand name: Sarclisa Dosage form: intravenous solution (irfc 20 mg/mL) Drug class: CD38 monoclonal antibodies Medically reviewed by Drugs.com on Apr 3, 2023. National Comprehensive Cancer Network. How is isatuximab given? Similarly, approximately twice as many patients in the isatuximabcarfilzomibdexamethasone group than the carfilzomibdexamethasone group who achieved CR also reached MRD-negative status (20.1% vs 10.6%; per ITT) [29, 31]. 8026], Spicka I, Moreau P, Martin TG, et al. The site is secure. The .gov means its official.Federal government websites often end in .gov or .mil. 4.2). The median number of prior lines of therapy was 3 (range 211); 56% of patients had received prior SCT; and 93%, 76%, 71% and 98% of patients were refractory to lenalidomide, a PI, lenalidomide plus a PI and their last line of therapy, respectively [28, 41]. Linear clearance of isatuximab predominates over the therapeutic plasma concentration range; clearance decreases over time by 50% to a steady state value of 9.55 mL/h (0.229 L/day) [16, 34]. As a library, NLM provides access to scientific literature. Changes resulting from comments received were made on the basis of scientific and editorial merit. Women's health is once again the center of a political ping-pong match with evidence-based science on one side and anti-choice advocates on the other. During the peer review process, the manufacturer of isatuximab was also offered an opportunity to review this article. bortezomib, carfilzomib and ixazomib), that are used, mostly in three-drug regimens that include a steroid, as front-line therapies for newly diagnosed disease in both transplant-eligble and -ineligible patients [46]. Isatuximab, an anti-CD38 IgG- mAb, is approved in several countries worldwide, including those of the EU [16], as well as the USA [17] and Japan [18]: in combination with pomalidomide and dexamethasone for adults with relapsed/refractory MM (RRMM) who have received 2 prior therapies [16-18] (including lenalidomide and a PI [16, 17] and who are refractory to their last therapy [16]); and in combination with carfilzomib and dexamethasone for adults with relapsed MM who have received 1 [16] or 13 [17] prior therapies. No effects of ADAs on the pharmacokinetics, safety or efficacy of isatuximab were observed [16]. Being exposed to isatuximab in the womb could affect your baby's vaccination schedule during the first few months of life. Moreau P, Dimopoulos MA, Mikhael J, et al. Keep using these medicines for as long as your doctor has prescribed. OS data were immature at the preplanned first interim analysis of this outcome, which was performed at the time of the primary PFS analysis [28]. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Ask your doctor about this risk. Common ARs occurring with both triplet regimens included IRs, respiratory infections and dyspnoea, with neutropenia being the most common AR in patients receiving isatuximabpomalidomidedexamethasone (or pomalidomidedexamethasone alone) and hypertension also being among the most common ARs in patients receiving isatuximabcarfilzomibdexamethasone (or carfilzomibdexamethasone alone). In: American Society of Hematology 62nd Annual Meeting. Haematological laboratory abnormalities leading to treatment discontinuation and/or dose modification and/or fulfilling a serious criterion were recorded as ARs [16]. In particular, head-to-head comparisons of isatuximab-based versus daratumumab-based regimens are keenly awaited. As optimal tolerance is the key for developing new treatments for the very elderly population, the aim of the study is to compare the efficacy and tolerance of isatuximab in combination with lenalidomide+dexamethasone (Rd) versus Rd only in very elderly patients aged 70 years or older. Your blood will need to be tested often. 2021. The combination of isatuximab and carfilzomib showed additive antimyeloma effects in a murine xenograft model utilizing the human MM.S1 MM cell line [32]. The introduction of IMiDs, PIs and anti-CD38 mAbs with their attendant improvements in survival is shifting the perception of MM from being an incurable disease to being a manageable chronic disease characterized by multiple relapses and salvage therapies; the goal of treatment is to achieve disease control with acceptable toxicity and HRQOL [9]. Dimopoulos MA, Moreau P, Terpos E, et al. 8014]. Sarclisa (isatuximab): assessment report. Fc-dependent activities include natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC), antibody-dependent cellular phagocytosis (ADCP) and complement-dependent cytotoxicity; ADCC and ADCP are the predominant immune effector mechanisms for isatuximab in MM cells [21]. This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDAs assessment. The original version of this article was revised due to a retrospective Open Access order. Isatuximab, particularly when combined with pomalidomide and dexamethasone, may cause neutropenia (Sect. Isatuximab plus pomalidomide and dexamethasone in frail patients with relapsed/refractory multiple myeloma: Icaria-MM subgroup analysis [abstract no. 4). In vivo vaccination effect in multiple myeloma patients treated with the monoclonal antibody isatuximab. Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDAsMedWatch Reporting System or by calling 1-800-FDA-1088. Shorter duration infusion times offer greater convenience to patients; in the absence of IRs, the infusion rate of isatuximab can be progressively increased, such that the first, second and all subsequent infusions can be delivered in 200, 113 and 75 min, respectively [16, 17] (Sect. Overall, grade 3 infections occurred in 43% of patients receiving isatuximabpomalidomidedexamethasone and 38% of those receiving isatuximabcarfilzomibdexamethasone. Clinical trial registries/databases and websites were also searched for relevant data. Zhu C, Song Z, Wang A, et al. In phase III studies, the addition of isatuximab to pomalidomide and dexamethasone significantly prolonged progression-free survival (PFS) and improved the depth of tumour response in patients with RRMM, as did the addition of isatuximab to carfilzomib and dexamethasone in patients with relapsed or refractory MM. Moreover, assessments of disease-relevant domains of the EORTC QLQ-C30 (GHS/QOL, PF, role functioning, pain and fatigue) and the EORTC myeloma-specific module (disease symptoms) suggested that HR-QOL in the subgroups of patients with RI and those with >3 previous lines of therapy was maintained better in patients receiving isatuximab combination therapy [38]. Esta actitud por parte del paparazzi . symptoms of pneumonia--cough with mucus, chest pain, feeling short of breath. Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754 New Zealand. Regarding the former, the multinational IONA-MM trial ({"type":"clinical-trial","attrs":{"text":"NCT04458831","term_id":"NCT04458831"}}NCT04458831) is an ongoing, prospective, non-interventional, observational study of 1100 patients with relapsed and/or refractory MM receiving isatuximabpomalidomidedexamethasone in routine clinical practice. In: American Society of Hematology 61st Annual Meeting. At baseline, the median age was 58 years (range = 26-70). 2021. Pending a successful outcome, the use of SC instead of IV isatuximab in combination with either pomalidomidedexamethasone or carfilzomibdexamethasone will increase the convenience of these regimens for patients. J. E. Frampton is a salaried employee of Adis International Ltd/Springer Nature, and declares no relevant conflicts of interest. All patients were premedicated prior to isatuximab infusions; the premedication regimen included the dexamethasone component of pomalidomidedexamethasone. Importantly, HRQOL is not adversely affected with the addition of isatuximab to pomalidomidedexamethasone or carfilzomibdexamethasone (Sect. Evaluating isatuximab interference with monoclonal protein detection by immuno-capture and liquid chromatography coupled to high resolution mass spectrometry in the pivotal phase 3 multiple myeloma trial, ICARIA-MM [abstract no. Most IRs occurred during the first infusion and were mild or moderate in intensity; all were reversible (Sect. As therapy for previously treated disease, isatuximabpomalidomidedexamethasone is a category 1, preferred regimen for the treatment of RRMM (indicated for patients who have received 2 prior therapies, including lenalidomide and a PI), while isatuximabcarfilzomibdexamethasone is a category 2A, other recommended regimen [52]. Usmani SZ, Karanes C, Bensinger WI, et al. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. 2). Isatuximab is eliminated by two parallel pathways: a nonlinear target-mediated pathway predominating at low concentrations and a nonspecific linear pathway predominating at higher concentrations [16]. Isatuximab-irfc was granted orphan drug designation. 2020. 4.1), while in IKEMA, the addition of isatuximab to carfilzomibdexamethasone significantly improved PFS in patients with relapsed or refractory MM who had received 13 prior lines of therapy (including IMiDs and PIs) (Sect. Pharmacoeconomic modelling studies based on indirect comparisons of efficacy suggest that, at 1 [58, 59] and 3 [58] (but not 5 [58]) years, there will be both clinical andfrom a USA payer perspectiveeconomic benefits favouring the use of IV isatuximab rather than IV daratumumb in combination with pomalidomidedexamethasone [58] or carfilzomibdexamethasone [59] to treat relapsed and/or refractory MM. You should not be treated with isatuximab if you are allergic to it. Sanofi-Aventis. Based on a population pharmacokinetic analysis, age, gender and race, as well as RI and hepatic impairment, have no clinically meaningful effects on the pharmacokinetics of isatuximab and do not require any dose adjustment [16, 34]. Mature OS data from both trials are awaited with considerable interest. Health-related quality of life was preserved. What should I avoid while receiving isatuximab? As well as Fc-mediated effector functions and direct anti-tumour effects, isatuximab has demonstrated immunomodulatory effects in vitro that may contribute indirectly to the control of tumour growth in MM [21, 24, 25]. The recommended isatuximab-irfc dose with carfilzomib and dexamethasone is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks until disease progression or unacceptable toxicity. Isatuximab is given after other cancer treatments did not work or have stopped working. As regards practical considerations, isatuximab, like daratumumab [55], may interfere with serological testing, as well as SPE and IFE (Sect. every 2 weeks) in the second and all subsequent 28-day cycles [16, 17]. Other baseline variables were balanced across treatment arms. Overall, patients had a median age of 64 years (40% were aged 65 years); 26%, 60% and 8% were at Revised-ISS stage I, II and III, respectively. 5). -Therapy is repeated until disease progression or unacceptable toxicity.Recommended Premedications (administer 15 to 60 minutes prior to the infusion):-Dexamethasone 40 mg orally or IV (or 20 mg orally or IV for patients 75 years or older).-Acetaminophen 650 mg to 1000 mg orally (or equivalent).-H2 antagonists.-Diphenhydramine 25 to 50 mg orally or IV (or equivalent). and transmitted securely. All authors contributed to the review and are responsible for the article content. An official website of the United States government, : Batch CBD Full-Spectrum Gummies. Furthermore, isatuximab binds to a CD38 epitope distinct from that targeted by daratumumab, and can be further differentiated from the latter on the basis of several mechanistic differences, including the ability to induce apoptosis of CD38-expressing cells directly (i.e. Isatuximab is the only anti-CD38 mAb that induces direct apoptosis in MM cell lines in the absence of cross-linking agents and . Improvements in PFS were also seen with the addition of isatuximab to pomalidomidedexamethasone in the subgroups of patients classified as frail [39] and those with soft-tissue plasmacytomas [37]. AEs adverse events, IR infusion reaction, ISA isatuximab, Kd carfilzomib and dexamethasone, Pd pomalidomide and dexamethasone, URTI upper respiratory tract infection. Call your doctor for medical advice about side effects. Randomization to isatuximabpomalidomidedexamethasone (n = 154) or pomalidomidedexamethasone alone (n = 153) was stratified according to the number of prior lines of therapy (23 vs >3) and age (<75 vs 75 years). HHS Vulnerability Disclosure, Help Global burden of multiple myeloma; a systematic analysis for the global burden of disease study 2016. Consistent with the ORR benefit seen in the overall population [odds ratio (OR) 2.795, 95% CI 1.754.56; p < 0.0001], ORRs were numerically higher with isatuximabpomalidomidedexamethasone than with pomalidomidedexamethasone in all prespecified subgroups, including patients aged 75 years, those with RI, those with high-risk cytogenetics, those with 23 or >3 previous lines of therapy, those refractory to lenalidomide, and those double-refractory to lenalidomide and a PI [28, 41, 42]. All patients with skin cancer continued isatuximab therapy after resection of the skin cancer [17]. Isatuximab plus carfilzomib and dexamethasone versus carfilzomib and dexamethasone in relapsed multiple myeloma patients who previously underwent transplantation: Ikema subgroup analysis [abstract no. Tell your caregiver if you feel cold, itchy, nauseated, feel like you might pass out, or have a cough, headache, stuffy or runny nose, a tight feeling in your throat, pounding heartbeats, fluttering in your chest, or trouble breathing. Local prescribing information should be consulted for detailed information regarding the dosage and administration of isatuximab, recommended premedication agents, serological testing, use in special patient populations, and warnings and precautions. "Vitamn C njdete v ovoc, ako s pomarane a jahody, a vitamn E v . Isatuximab was added at an intravenous dose of 10 mg/kg in cycle 1 on days 1, 8, 15, 22, and 29, as well as cycles 2 through 3 on days 1, 15, and 29. Subgroup analysis of ICARIA-MM study in relapsed/refractory multiple myeloma patients with high-risk cytogenetics. You may need to use the medicine only during certain days of each cycle. Common side effects of isatuximab may include: cold symptoms such as stuffy nose, sneezing, sore throat; This is not a complete list of side effects and others may occur. Isatuximab is given as an infusion into a vein. 10 mg/kg (actual body weight) IV qWeek (eg, Day 1, 8, 15, 22) Joint European Hematology Association (EHA) and European Society for Medical Oncology (ESMO) clinical practice guidelines for managing MM, including relapsed/refractory disease, have been published recently [51]. Isatuximab prolonged progression-free survival (PFS) and increased the frequency and/or depth of tumour response when added to pomalidomide and dexamethasone in adults with RRMM who had received 2 previous lines of treatment (ICARIA-MM trial), and when added to carfilzomib and dexamethasone in adults with relapsed or refractory MM who had received 1 previous lines of treatment (IKEMA trial). Based partly on the results of an ongoing phase 1b study [44], patients in the isatuximab arm received IV isatuximab 10 mg/kg weekly for 4 weeks and then every 2 weeks; patients in both arms received IV carfilzomib twice weekly for the first 3 weeks of each cycle (20 mg/m2 on days 1 and 2 of cycle 1; 56 mg/m2 on days 8, 9, 15 and 16 of cycle 1 and thereafter) and dexamethasone 20 mg twice weekly (on days 1, 2, 8, 9, 15, 16, 22 and 23 of each cycle; IV on days of isatuximab and/or carfilzomib infusions; orally on other days) [29, 32]. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) 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. You may report side effects to FDA at 1-800-FDA-1088. Dimopoulos MA, Leleu X, Moreau P, et al. Pomalidomide can cause severe, life-threatening birth defects with just one dose. Martin TG, Corzo K, Chiron M, et al. The site is secure. Npoje s vysokm obsahom antioxidantov, ako s vitamny C a E, preukzatene zlepuj erektiln funkciu tm, e brnia pokodeniu buniek, produkujcich oxid dusnat," hovor Pearlmanov. Medical uses In the United States it is indicated, in combination with pomalidomide and dexamethasone ( video about this from ASH 2022 ), for the treatment of adults with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. 8017], Beksac M, Richardson PG, Unal A, et al. Currently available data indicate that the combinations of isatuximab with pomalidomidedexamethasone and carfilzomibdexamethasone are important additional treatment options for adults with RRMM and relapsed MM, respectively. Isatuximab plus pomalidomide and dexamethasone in patients with relapsed/refractory multiple myeloma and soft-tissue plasmacytomas: ICARIAf-MM subgroup analysis [abstract no. weekly) in the first 28-day treatment cycle and days 1 and 15 (i.e. The trial randomized 302 patients (3:2) to receive isatuximab-irfc with carfilzomib and dexamethasone (Isa-Kd) or carfilzomib and dexamethasone (Kd). Moreau P, Attal M, Facon T. Frontline therapy of multiple myeloma. Isatuximab is used treat multiple myeloma in adults. Compared with isatuximab alone, isatuximab plus pomalidomide enhanced in vitro killing of CD38+ MM cells via both ADCC and direct anti-tumour effects to a greater extent than isatuximab plus lenalidomide [23]. Isatuximab is used treat multiple myeloma in adults. (Fig.2).2). The incidence of treatment-emergent anti-drug antibodies (ADAs) was 1.9% across nine clinical studies of isatuximab as monotherapy or in combination therapy in patients with MM, including ICARIA-MM and IKEMA (n = 1018) [16]. An isatuximab-related PFS advantage was seen across almost all prespecified subgroups, including patients aged 70 years, those with RI, those with high-risk cytogenetics, those with 1q21 gain, those with 1 or >1 previous lines of therapy, those with prior IMiD or PI treatment, and those refractory to lenalidomide [29, 48, 49]. Sanofi Co., Ltd. Sarclisa intravenous infusion 100mg/Sarclisa intravenous infusion 500mg: Japanese prescribing information. In the interim, median PFS and OS have been estimated to be, respectively, 5 and 8 months longer with isatuximabpomalidomidedexamethasone than with daratumumabpomalidomidedexamethasone, based on an indirect comparison of these two regimens that used data from the ICARIA-MM study for the former and data from a phase 1b study in patients with relapsed and/or refractory MM for the latter [54]. Whereas isatuximab was administered in a weight-based infusion volume in ICARIA-MM and IKEMA, the approved method is administration in a 250 mL fixed infusion volume [16, 17] (Sect. 2021. Clinical trial design for the phase III ICARIA-MM and IKEMA trials, with key efficacy results in the animated figure (available online). Permanently discontinue for grade 4 infusion-related . IRs led to the interruption of and the discontinuation of isatuximab in, respectively, 28.9% and 2.6% of patients who received the drug in ICARIA-MM, and 29.9% and 0.6% of patients who received the drug in IKEMA [16]. As a large protein, isatuximab is expected to be metabolized into small peptides by non-saturable proteolytic catabolism processes [16, 17]. A phase 1b study of isatuximab plus pomalidomide/dexamethasone in relapsed/refractory multiple myeloma. The recommended isatuximab-irfc dose is 10 mg/kg as an intravenous infusion every week for 4 weeks followed by every 2 weeks in combination with pomalidomide and dexamethasone until disease progression or unacceptable toxicity. Martin TG, Capra M, Mohty M, et al. Martin T, Mikhael J, Hajek R, et al. The ongoing ICARIA-MM and IKEMA studies are the first phase III trials to evaluate and demonstrate the benefits of isatuximab combination therapies in patients with MM. Targeting CD38 suppresses induction and function of T regulatory cells to mitigate immunosuppression in multiple myeloma. Multiple myeloma: 2020 update on diagnosis, risk-stratification and management. SPMs occurred in six patients (3.9%) treated with isatuximabpomalidomidedexamethasone [vs one (0.7%) treated with pomalidomidedexamethasone] in ICARIA-MM, and 13 (7.3%) treated with isatuximabcarfilzomibdexamethasone [vs six (4.9%) treated with carfilzomibdexamethasone] in IKEMA [17]. Written by Cerner Multum. 4), isatuximab interference with M-protein detection was explored using mass spectrometry (MS) to separate the isatuximab and M-protein signals [30, 31]. ulcers, sores, or white spots in the mouth. Indicated, in combination with carfilzomib and dexamethasone, for adults with relapsed or refractory multiple myeloma who have received 1-3 prior lines of therapy. 1371]. Dosage form: intravenous solution (irfc 20 mg/mL) in the absence of cross-linking agents) [15]. 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