Teclistamab is another extensively studied T cell receptor, presenting an IgG format. National Center for Advancing Translational Sciences (NCATS), ANTI-CD3/ANTI-BCMA BISPECIFIC MONOCLONAL ANTIBODY PF-06863135, IMMUNOGLOBULIN G2-KAPPA, ANTI-(HOMO SAPIENS T-CELL SURFACE GLYCOPROTEIN CD3 EPSILON CHAIN CD3E (T-CELL SURFACE ANTIGEN T3/LEU-4 EPSILON CHAIN)), HUMAN-MUS MUSCULUS MONOCLONAL DISULFIDE WITH IMMUNOGLOBULIN G2-KAPPA, ANTI-(HOMO SAPIENS-TUMOR NECROSIS FACTO, IMMUNOGLOBULIN G2 (224-ARGININE,265-ALANINE,330-SERINE,331-SERINE), ANTI-(HUMAN CD3 ANTIGEN .EPSILON.-CHAIN) (HUMAN-MUS MUSCULUS MONOCLONAL PF-06863059 .GAMMA.2-CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS MONOCLONAL PF-06863059 .KAPPA.-CHAIN, (223->217')(2, B-CELL MATURATION ANTIGEN (BCMA) CLUSTER OF DIFFERENTIATION 3 (CD3) BISPECIFIC MONOCLONAL ANTIBODY (MAB) ANTI-BCMA/ANTI-CD3 BISPECIFIC MAB, U.S. Department of Health & Human Services, https://clinicaltrials.gov/ct2/show/NCT04649359. Multiple Myeloma Trial in Worldwide (Elranatamab - Clincosm Elranatamab. Search for other works by this author on: 2021 by The American Society of Hematology. Response was assessed by International Myeloma Working Group (IMWG) criteria. These results, along with emerging combination data, support continued development of elranatamab as a single agent and in combination with standard therapies for MM. Advertisers, Journal of Clinical Oncology MM is a blood cancer that affects plasma cells made in the bone marrow. This marks Pfizers twelfth FDA Breakthrough Therapy Designation in Oncology, a testament to our relentless commitment to developing transformational cancer medicines in areas of high unmet need. Copyright 2022 by American Society of Hematology, 653.Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials, https://doi.org/10.1182/blood-2021-150519. MagnetisMM-7 - Multiple Myeloma Clinical Trials Cookies. Elranatamab is administered subcutaneously, which offers more convenience over intravenous administration, and may mitigate the risk of potential adverse events, such as cytokine release syndrome (CRS). Reviewers In addition, to learn more, please visit us on www.Pfizer.com and follow us on Twitter at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Pfizer Gets FDA Breakthrough Designation for Elranatamab Clinical trial information: NCT03269136. Globocan 2020: Multiple Myeloma. Pfizer's multiple myeloma treatment granted FDA Breakthrough Therapy We routinely post information that may be important to investors on our website at www.Pfizer.com. Lesokhin:pfizer: Consultancy, Research Funding; Behringer Ingelheim: Honoraria; Trillium Therapeutics: Consultancy; bristol myers squibb: Research Funding; Genetech: Research Funding; Iteos: Consultancy; Janssen: Honoraria, Research Funding; Serametrix, Inc: Patents & Royalties. Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and the CD3 receptor found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. Gasparetto:Janssen: Consultancy; Sanofi: Consultancy, Honoraria, Speakers Bureau; Oncopeptide: Consultancy, Honoraria, Speakers Bureau; Karyopharm: Consultancy, Honoraria, Speakers Bureau; Gsk: Consultancy, Honoraria, Speakers Bureau. NEW YORK--(BUSINESS WIRE)-- pfe-20210202 - SEC Conquer Cancer Foundation X. ChemIDplus is moving to PubChem in December 2022. In this interim analysis, safety and efficacy was analyzed in 94 patients who had received at least one dose of elranatamab (Cohort A - BCMA-nave) as of the data cutoff on March 23, 2022. Updated data, including duration of response, will be presented. TAPUR Study, Terms of Use | Privacy Policy | Elranatamab - Single-patient Expanded Access - Multiple Myeloma ASCO Connection At the RP2D of 1000g/kg, median duration of CRS decreased by 50% from 4 days to 2 days with priming. Permissions, Authors Available at: https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/breakthrough-therapy Accessed September 23, 2022. Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and the CD3 receptor found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. Results: 30 pts had received elranatamab as of 4-Aug-2020 at 80 (n = 6), 130 (n = 4), 215 (n = 4), 360 (n = 4), 600 (n = 6), or 1000 (n = 6) g/kg SC weekly. Exposure increased with dose, cytokine increases occurred with the first dose, and increased T-cell proliferation was observed in peripheral blood. JCO Oncology Practice Pfizer Elranatamab gets USFDA Breakthrough Therapy Designation for Archive published online before print Median duration of follow-up was 7.5, 2.3, and 1.9 months for the dose escalation, priming, and LEN/POM combination cohorts, respectively. Available at: https://gco.iarc.fr/today/data/factsheets/cancers/35-Multiple-myeloma-fact-sheet.pdf. Main Content- Elranatamab is a BCMA x CD3-targeted investigational therapy currently being developed to treat multiple myeloma. Elranatamab in Multiple Myeloma - CancerConnect Pfizer's Elranatamab Granted FDA Breakthrough Therapy Designation for The most common treatment-emergent adverse event (TEAE) regardless of causality was CRS (57.9%), with the majority of events reported being either Grade 1 (43.2%) or Grade 2 (14.2%). The FDA and EMA have granted elranatamab Fast Track Designation and the PRIME scheme, respectively, for the treatment of patients with RRMM. JCO Global Oncology FDA Grants Breakthrough Therapy Designation to Elranatamab for Relapsed Patient selection for CAR T or BiTE therapy in multiple myeloma: Which J Clin Oncol. 3 World Health Organization. In partnership with. 2408850-14-4 - Elranatamab - Searchable synonyms, formulas, resource links, and other chemical information. The purpose of the study is to evaluate whether single-agent Elranatamab (PF-06863135) can provide clinical benefit in participants with relapsed/refractory multiple myeloma. PDF Bispecificantibodies Skoura:Pfizer: Current holder of individual stocks in a privately-held company, Current holder of stock options in a privately-held company. Elranatamab is designed to bind to BCMA, which is highly expressed on the surface of multiple myeloma (MM) cells, and the CD3 receptor found on the surface of T-cells, bridging them together and activating the T-cells to kill the myeloma cells. Pronunciation of elranatamab with 1 audio pronunciation, 1 meaning and more for elranatamab. ASCO Daily News Help; FAQs; Fact Sheet; So the MagnetisMM-3 Study was a Phase 2 evaluation of elranatamab, a BCMA CD3 bispecific antibody, in two groups of patients: those with multiple myeloma that were refractory to an IMiD, a proteasome inhibitor and an anti-C38 antibody, and had either never received prior BCMA-directed therapy or had previously received BCMA-directed antibody drug, conjugate, or CAR T cell therapy. The UK Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted elranatamab Innovative Medicine Designation and the Innovation Passport, for the treatment of MM. Pfizer's Elranatamab Granted FDA Breakthrough Therapy Designation for Among responders, there was 90.4% probability of maintaining a response 6 months. Elranatamab receives breakthrough therapy designation for advanced RG6234. Novel immunotherapy shows robust response for multiple myeloma | VUMC Elranatamab has been. Efficacy and safety of elranatamab (PF-06863135), a B-cell maturation Pfizer's Elranatamab Granted FDA Breakthrough Therapy Designation for Exposure was dose dependent and Q2W dosing achieved exposure associated with anti-myeloma efficacy. Across the efficacious dose range, elranatamab achieved confirmed ORR of 70% and CR/sCR rate of 30%, with confirmed ORR of 83% at the RP2D. Department of Medicine, University of Chicago Medical Center, Chicago, IL; Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada; Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Moores Cancer Center, University of California San Diego, La Jolla, CA; Vanderbilt University Medical Center, Nashville, TN; Blood and Marrow Transplant Group of Georgia, Northside Hospital, Atlanta, GA; Department of Medical Oncology, Baylor Scott and White Health, Dallas, TX; Holden Comprehensive Cancer Center, University of Iowa, Iowa City, IA; Oncology Research and Development, Pfizer, San Diego, CA; Early Clinical Development, Pfizer, San Diego, CA; Early Clinical Development, Pfizer, Collegeville, PA; Oncology Research and Development, Pfizer, South San Francisco, CA; Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada; Cross Cancer Institute, Edmonton, AB, Canada; Department of Medicine, Duke University Cancer Institute, Durham, NC; Department of Hematology and Oncology, Ochsner Health, Jefferson, LA; Cedars Cancer Center, McGill University Health Center, Montreal, QC, Canada; Division of Hematology and Oncology, Memorial Sloan Kettering Cancer Center/Weill Cornell Medical College, New York, NY, Professional English and Academic Editing Support, https://doi.org/10.1200/JCO.2022.40.16_suppl.8014, 2318 Mill Road, Suite 800, Alexandria, VA 22314, 2022 American Society of Clinical Oncology. , will be presented and EMA have granted Elranatamab Fast Track Designation the. 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