Abecma clinical trial. Abecma was approved by the U.

Abecma clinical trial Abecma is the first cell-based gene therapy approved by the FDA for the treatment of Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. found on multiple myeloma cells called a B-cell maturation antigen, or BCMA BCMA: A protein that is found on the outside of nearly all multiple myeloma cells and on Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www. 1 Clinical Trials Experience. This is an ASCO Meeting Abstract from the 2021 ASCO Annual Meeting I. 2 Immunogenicity 6. The companies blamed the improving treatment landscape for the discontinuation of the Karmma-9 trial, adding that they were seeing “considerably fewer eligible patients Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. Apr 8, 2024 · The Abecma and Carvykti labels are now updated with an additional warning that in clinical trials, a greater number of patients in the treatment arms experienced an early death compared to the Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. 8 months in 128 patients treated with Abecma, representing the longest follow-up to date from a global clinical trial of a CAR T cell therapy in multiple myeloma, the overall response rate (ORR; primary endpoint) remained consistent, with 73% (94/128) of patients achieving a partial response or better and 33% (42/ This document summarizes the basis for regular approval of ABECMA. Mar 30, 2022 · The approval was based on results from a small clinical trial in which cilta-cel reduced the amount of cancer in nearly every participant and, for many, kept their cancer in check for more than a year. is the only phase 3 Phase 3 (also known as Phase III): A study that tests the safety and how well a new treatment Dec 6, 2024 · ABECMA is the treatment of adult patients with relapsed or Refer to Section 1. 3 Postmarketing Sep 30, 2024 · In another blow to Abecma, BMS and 2seventy last week decided to discontinue the phase 3 KarMMa-9 trial, which had been evaluating Abecma as a first-line maintenance treatment in patients with U. Jun 5, 2023 · Carvykti’s 85% improvement appeared better than the 54% that Abecma posted for a similar triple class-refractory patient group in a separate phase 3 trial coded KarMMA-3. 1 effective August 7, 2019. The FDA will review Carvykti and Abecma‘s supplemental Biologics License Applications (sBLA) further, which is a necessary step during the drug approval process. Dec 11, 2024 · Abecma also received a label expansion in the same patient population but who had received two prior lines of treatment. CAR T-cell therapy is associated with Dec 31, 2024 · Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. These are results experienced by people in the ABECMA clinical trial. Aug 15, 2024 · The rate of cytokine release syndrome (CRS) was 46% in the linvoseltamab 200 mg group, and it occurred in 76%, 72%, 58%, 78% and 91% of patients in the talquetamab-tgvs (Talvey), teclistamab-cqyv (Tecvayli), and elranatamab-bcmm (Elrexfio), ciltacabtagene autoleucel (Carvykti) and idecabtagene vicleucel (Abecma) trials, respectively Cytokine Release Syndrome (CRS) (cont’d): Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. March 26, 2021 Sep 25, 2024 · After KarMMa-9, there are no phase 3 trials for Abecma in first-line treatment. Sep 26, 2024 · Bristol Myers Squibb (BMS) and 2seventy bio have announced plans to discontinue enrolment of subjects in the Phase III KarMMa-9 clinical trial of Abecma (idecabtagene vicleucel) for newly diagnosed multiple myeloma patients (NDMM). Mar 20, 2024 · Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile with mostly low-grade and transient occurrences of cytokine release syndrome and neurotoxicity Approval reinforces Bristol Myers Squibb’s commitment to bring the transformative potential of cell therapy into Sep 25, 2024 · Struggling 2Seventy scraps a key cancer study The biotech expects that stopping enrollment for KarMMa-9, a trial evaluating early use of multiple myeloma cell therapy Abecma, should save it $80 million in the near term. Abecma. Inside your body, ABECMA CAR T cells look for a protein Protein: These are the building blocks that make up many different parts of your body, including your skin, hair, and substances like cytokines. Abecma is a first-in-class BCMA-directed personalized immune cell therapy delivered as a one-time infusion for triple-class exposed patients with multiple myeloma1 In the pivotal KarMMa trial, the majority (72%) of patients achieved rapid, deep and durable responses1 Safety profile of Abecma is well-established and predictable including cytokine release syndrome and neurologic toxicities that Aug 31, 2021 · This document summarizes the basis for regular approval of ABECMA. Abecma was approved by the U. 6 Sep 25, 2024 · 2seventy bio and Bristol Myers Squibb have given up on first-line multiple myeloma with their BCMA-targeting Car-T therapy Abecma, just a year after a phase 3 study was begun. With these FDA approvals, more patients will be able to access this innovative treatment early. The clinical trial that led to FDA approval of Abecma for multiple myeloma showed that of 100 participants, 72% (72 patients) experienced overall response, a meaningful decrease in the signs of myeloma. 4. Idecabtagene vicleucel, sold under the brand name Abecma, is a cell-based gene therapy to treat multiple myeloma. Mar 29, 2021 · Abecma is engineered to target a different cancer protein, B-cell maturation antigen (BCMA). Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. fda. Our STN: BL 125736/0 . View Cellular Therapy clinical trials. 24 REMS facility and diagnosis codes for autologous CAR T-cell therapy ICD-10-PCS codes in the chart above in qualifying clinical trials under NCD 310. Mar 20, 2024 · Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile with mostly low-grade and transient occurrences of cytokine release syndrome and neurotoxicity Approval reinforces Bristol Myers Squibb’s commitment to bring the transformative potential of cell therapy into Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. 3 months vs. † T cell T cell: A type of cell found in the body’s immune system that plays a role in fighting disease, including cancer. -based multicenter phase 1b/2 clinical trial (NCT03548207) aimed to assess the safety and clinical efficacy of ciltacabtagene autocleucel (cilta-cel). 8bn and Abecma $853m in the same year. Clinical trial data have demonstrated high efficacy for r/r B-cell. The CMRG noted that patients with other poor prognosis factors, such as extramedullary disease and experience with high-risk cytogenetics, do not fare significantly worse, and older age does not appear to be an exclusion factor. Methods A retrospective cohort study was conducted at John Theurer Cancer Center, including R/R MM patients who underwent CAR-T therapy from January 2018 to December 2023. A single clinical trial, Study BB2121-MM001 (MM-001), provides the primary evidence of safety and efficacy for the BLA submission. Multiple myeloma is a cancer where plasma cells rapidly divide out of control. 1 Clinical Trials Experience 6. It is a personalised immunotherapy that identifies and binds to BCMA, causing the death of the BCMA-expressing cells. This phase I trial studies the safety, side effects, best dose and effectiveness of mezigdomide (CC-92480) when given after idecabtagene vicleucel (Abecma chimeric antigen receptor [CAR] T-cell therapy) in patients with multiple myeloma that has come back after a period of improvement Aug 10, 2022 · Bristol Myers Squibb and partner 2Seventy bio see potential for earlier use of their multiple myeloma treatment Abecma after reporting clinical trial results that showed the CAR-T cell therapy outperformed standard drug regimens. Jun 25, 2021 · EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Abecma (idecabtagene vicleucel) for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least three previous therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and whose cancer has worsened since Mar 20, 2023 · The CARTITUDE-1 study was a single-arm, open-label, U. Jan 9, 2023 · Idecabtagene vicleucel (ide-cel) is an autologous B-cell maturation antigen–directed chimeric antigen receptor T-cell therapy approved for relapsed/refractory multiple myeloma (RRMM) on the basis of the phase II pivotal KarMMa trial, which demonstrated best overall and ≥ complete response rates of 73% and 33%, respectively. announced the positive topline results from KarMMa-3—a Phase 3, global, randomized, multicenter, open-label study evaluating ABECMA® (idecabtagene vicleucel) compared to standard combination regimens in adults with multiple myeloma that is relapsed and refractory after two to four prior lines of therapy and refractory to Jun 6, 2021 · Abecma (idecabtagene vicleucel ; ide-cel; formerly bb2121), a chimeric antigen receptor (CAR)-T cell therapy, led to improved survival in patients with multiple myeloma who have been treated with many other lines of therapy, according to updated results from the KarMMa trial presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. reported. Here’s how ABECMA works. gov . Abecma was previously FDA-approved for use in myeloma after at least 4 prior lines of therapy. In 2 ABECMA clinical studies, most people did not experience neurologic toxicity: *The median ‡ time to onset was 2 days, with a range of 1 to 148 days. 6 months of median follow-up. See the following websites for specific REMS facility information: • Kymriah® • Yescarta® • Tecartus™ • Breyanzi® • ABECMA® Dec 19, 2022 · The FDA approval of Abecma was based on the pivotal KarMMa study, which is an open label, single arm, multicenter phase 2 clinical trial (NCT03361748). 6 clinical trial diagnosis code Mar 13, 2024 · The requests are supported by large trials of Carvykti and Abecma that each enrolled hundreds of participants. Additional Options. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted positively (8-3) that Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma based on results from the Mar 15, 2024 · Even though the BCMA CAR-T therapies Carvykti and Abecma showed a potential problem of early patient deaths in their separate trials, experts on the FDA’s Oncologic Drugs Advisory Committ Mar 15, 2024 · Federal drug regulators are raising concerns over clinical trial deaths among patients given Carvykti and Abecma, indicating that the deaths appear to be linked to side effects of the CAR-T Mar 21, 2024 · The decision is based on the results from the KarMMa-3 study, a Phase III, open-label, global, randomised, controlled clinical trial. Feb 24, 2021 · CAR T-cell therapy landscape in pediatric, adolescent and young adult oncology – A comprehensive analysis of clinical trials, Critical Reviews in Oncology/Hematology, 209, (104648), (2025 This ABECMA study KarMMa-3: The registrational clinical study that was the basis for the FDA approval of ABECMA for patients with triple-class exposed relapsed/refractory multiple myeloma who had received at least 2 prior regimens. It is not a substitute for medical advice. Dec 10, 2024 · The clinical trials that first led to Carvykti's and Abecma's approvals were single-arm trials. Jul 29, 2024 · Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Jan 31, 2025 · However, the ongoing clinical trial could pave the way for the drugs to be approved for multiple myeloma patients earlier in their treatment journey. 2 Multiple myeloma is typically treated with an immunomodulatory agent like lenalidomide, 6 a proteasome Mar 18, 2024 · FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted positively that Bristol Myers Squibb’s and 2seventy bio’s Abecma (idecabtagene vicleucel) demonstrated a favorable benefit/risk profile for patients with triple-class exposed relapsed or refractory multiple myeloma, according to a press release. This abstract does not include a full text component. In addition, our pediatric immune effector cell program may offer some children and young adults the opportunity to enroll in clinical trials on CAR-T cell products. There were very specific inclusion/exclusion criteria for eligibility which are listed in the Table Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients with Relapsed Multiple Myeloma. Important: The drug information on this page is meant to be educational. May 28, 2021 · Clinical trial information: NCT04196491. Each clinical trial is designed to find better ways to prevent, detect, diagnose, or treat cancer and to answer scientific questions. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease has returned after, at least four prior lines (different types) of therapy. Mar 31, 2021 · Generic Name Idecabtagene vicleucel DrugBank Accession Number DB16665 Background. Our recommendation for approval is based on the overall response rate, complete response rate and duration of response demonstrated in this study. -associated neurologic toxicity resolved in 123 of 139 (88%) patients and median ‡ time to resolution was 5 days Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Clinical Trials and Abecma . Dec 1, 2021 · For Immediate Release: March 27, 2021: The U. 1 The vote is based on positive results from the pivotal Phase III KarMMa-3 study Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. BLA APPROVAL . acute lymphoblastic leukemia, and lasting remissions have been. BMS/2seventy currently do not have plans to start another phase 3, but the partners will “continue expanding the Mar 13, 2024 · The FDA has raised concerns about early clinical trial deaths as part of two applications that aim to move the CAR-T therapies Carvykti and Abecma into earlier lines of treatment for multiple myeloma. Specifically, the FDA raised concerns about the “higher rate of early deaths” in the clinical trials of both Abecma and Carvykti. Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. ABECMA was studied in adults with RRMM In the ABECMA clinical trial: All patients had received at least 3 other kinds of treatment that had not worked or had stopped working— including an IMiD ® agent, a proteasome inhibitor, and an anti-CD38 antibody; 100 adults with RRMM were treated with ABECMA Jan 31, 2023 · Medicare contractors will not require NCD 110. Find Clinical Trials for Idecabtagene Vicleucel - Check for trials from NCI's list of cancer clinical trials now accepting patients. Jul 20, 2021 · We will cover routine costs in clinical trials that use CAR T-cell therapy as an investigational agent that meet the requirements listed in NCD 310. ” Jul 11, 2023 · Abecma’s Phase III KarMMa-3 trial (NCT03651128) is enrolling 381 patients who have received at least two but no greater than four prior regimens. Food and Drug Administration approved Abecma (idecabtagene vicleucel), a cell-based gene therapy to treat adult patients with multiple myeloma who have not responded to, or whose disease INDICATION. l. INDICATION. Clinical trials on Abecma Nov 5, 2024 · This study aims to compare the clinical outcomes and safety profiles of Carvykti and Abecma in R/R MM patients outside of controlled clinical trial settings. S. COMPLETE RESPONSE OR BETTER OVERALL RESPONSE RESPONSE RESULTS 29% (29 out of 100 patients) 72% (72 out of 100 patients) TARGET DOSE (450 million cells) 39% (21 out of 54 patients) 82% (44 out of 54 patients) IMPORTANT SAFETY INFORMATION (cont’d) We would like to show you a description here but the site won’t allow us. A single clinical trial, Study BB2121-MM001 (MM-001), provides the primary evidence of safety and efficacy for the Apr 5, 2024 · Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile Expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering Based on clinical trial experience, your ABECMA will be ready to be shipped back to your healthcare provider about 4 weeks after your cells are received at the manufacturing site, but the time may vary. Dec 9, 2024 · Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Abecma was shown to improve progression-free survival, the trial’s primary endpoint, at pre-specified interim analysis with 18. Analyzing the data, however, FDA reviewers identified better survival for patients on standard of care regimens, which included such medications as Darzalex and Pomalyst. Clinical trial data have demonstrated encouraging results for r/r. 1 of the Clinical Review Memo for information about participation in the clinical trials and any analysis of Aug 10, 2022 · The companies thank the patients and investigators who are participating in the KarMMa-3 clinical trial. Feb 10, 2023 · The KarMMa-3 trial was a phase 3, randomized, clinical trial for the direct comparison of a CAR T-cell therapy with standard regimens in triple-class–exposed relapsed and refractory multiple Feb 10, 2023 · Abecma more than tripled progression-free survival (13. Mar 15, 2024 · According to this March 15, 2024, press release from Bristol Myers Squibb and 2seventy bio, "the U. Geriatrics (≥ 65 years of age): In the single-arm Phase II KarMMa clinical trial Abecma, 45 (35%) of the 128 patients treated with Abecma were 65 years of age or older. 2 These cancerous cells generally express the B-cell maturation antigen, while it is rarely expressed on non-cancerous cells. Medicare contractors will not require NCD 110. 3 Postmarketing Experience. 6. Abecma was approved by the FDA in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Clinical Trials Accepting Patients. 6 days ago · Safety meanwhile was also encouraging and in line with earlier trials of Abecma, according to a company statement, For its part, Abecma made $89 million in the second quarter, up 36% on the The U. A clinical trial is a medical research study with people who volunteer to test scientific approaches to a new treatment or a new combination therapy. 2 Immunogenicity. chronic lymphocytic leukemia and non-Hodgkin lymphoma, with durable remissions reported. ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. For example, you may be eligible to participate in clinical trial evaluating the effectiveness of cell therapy for sarcoma, prostate cancer, melanoma, or other cancer types. [ 3 ] [ 7 ] [ 8 ] The most common side effects include cytokine release syndrome (CRS), infections, fatigue , musculoskeletal pain, and a weakened immune system ( hypogammaglobulinemia ). 4 months in the control arm with standard regimens. Aug 29, 2022 · The KarMMa-3 Phase 3 clinical trial, which has met its primary goal, also showed that the treatment safely led to an improvement in the overall response rate — a key secondary goal that assessed the proportion of patients who achieved a partial or complete response to the therapy — compared to standard regimens. Aug 10, 2022 · On Wednesday, August 10, Bristol Myers Squibb and 2seventy bio, Inc. 1 billed with the national clinical trial (NCT) number for the specific trial, cond ition code (CC) 30, value code (VC) D4, and the ICD-10 code Z00. Mar 20, 2024 · Abecma demonstrated superiority over standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile with mostly low-grade and transient occurrences of cytokine release syndrome and neurotoxicity Approval reinforces Bristol Myers Squibb’s commitment to bring the transformative potential of cell therapy into Mar 15, 2024 · But the outcome for Abecma may not be so positive, according to briefing documents released earlier this week. ABECMA is shipped directly to the cell laboratory or clinical pharmacy associated with the infusion. Leading data and analytics company GlobalData’s analyst consensus forecast predicts that global sales for Anito-cel will be $505m in 2030 while Carvykti will reach $9. 1 May 19, 2021 · With a median follow-up of 24. As such, they didn't prove their respective CAR T-cell therapies were any more effective than existing multiple myeloma therapies — including other treatments in the same class. Jan 12, 2023 · This sBLA contains the results of a single, randomized controlled trial (KarMMa 3) of idecabtagene vicleucel (trade name: ABECMA; hereby referred to as ide-cel), an autologous, anti-B-cell maturation Dec 6, 2022 · ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. Apr 8, 2024 · Previously, CARVYKTI and ABECMA were only allowed for patients who had failed at least four lines of therapy. The study, which recruited its first patient in April 2019, has data expected sometime between 2023 and 2024, according to an April 2022 presentation. Food and Drug Administration (FDA) in March 2021 for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Your results may be different. Apr 5, 2024 · Abecma tripled progression-free survival compared to standard regimens in the Phase 3 KarMMa-3 trial, with a 51% reduction in risk of disease progression or death and a well-established safety profile Expanded approval brings this personalized CAR T cell therapy to more patients with relapsed or refractory multiple myeloma earlier in their treatment journey as a one-time infusion offering ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous 6. We would like to show you a description here but the site won’t allow us. 1 billed with the national clinical trial (NCT) number for the specific trial, condition code (CC) 30, value code (VC) D4, and the ICD-10 code Z00. Some of the main eligibility criteria for this study were: patients were 18 years of age or older and diagnosed with MM; Jan 21, 2025 · However, in an email to BioSpace, a BMS spokesperson said, “Data comparisons from separate trials investigating Abecma or Carvytki in certain patients with multiple myeloma are not appropriate, as each trial has different patient populations, study designs, and treatment comparators. Feb 28, 2025 · Abecma's FDA approval was based on positive results from the clinical trial KarMMa-3 Study Abecma patients had a success rate of: 72% overall response rate (ORR) 28% achieved a stringent complete response; 25% had a very good partial response; 19% achieved a partial response Apr 18, 2024 · This approval is based on data from the KarMMa-3 phase III clinical trial, which demonstrated a PFS of roughly 13 months in the Abecma arm of the study vs. Results of the clinical trial were published last month in the New England Journal of Medicine Aug 19, 2021 · Abecma represents the only cell therapy approved for multiple myeloma Approval of Abecma is based on the pivotal KarMMa trial of patients worldwide, including five European countries, which demonstrated rapid, deep and durable responses with a well-understood and predictable safety profile Abecma expands upon Bristol Myers Squibb’s leadership in cell therapy research and multiple myeloma Mar 4, 2022 · Abecma is a first-in-class genetically modified autologous CAR-positive T-cell therapy directed to B-cell maturation antigen (BCMA), a protein expressed on the malignant cells in multiple myeloma. Overall, 24% (82/349) of patients received at least 1 dose of corticosteroids for treatment of CRS. On March 26, 2021, the Food and Drug Administration approved idecabtagene vicleucel (Abecma, Bristol Myers Squibb) for the treatment of adult patients with relapsed or refractory multiple myeloma Clinical trials. 4 months) compared with standard regimens for triple-class exposed multiple myeloma Safety results were consistent with the well-established and predictable safety profile of Abecma Abecma is the first and only CAR T cell therapy to demonstrate superiority over standard regimens in triple-class exposed relapsed and Of the 349 patients who received ABECMA in clinical trials, 226 (65%) patients received tocilizumab; 39% (135/349) received a single dose, while 26% (91/349) received more than 1 dose of tocilizumab. Like the first FDA-approved CAR T-cell therapy for multiple myeloma, cilta-cel targets a protein on myeloma cells called BCMA. No clinically important differences in the safety or effectiveness of Abecma were observed between these The DAC added that the clinical trial recruited patients with a good performance status. fxx otcvz ihhsce shlwpx npldv fhwmilx jvteq xvbrn bwon dkssfy sfdhz eijog pilf seromp wjjvj