Recent Results Cancer Res. Bristol-Myers Squibb Company (NYSE:BMY) and AbbVie (NYSE:ABBV) today announced the U.S. Food and Drug Administration (FDA) has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. Multiple myeloma (MM) is the second most common hematologic malignancy characterized by the expansion and accumulation of clonal plasma cells (PCs) in the bone marrow (BM). Krystal Loewe The "Yes" link below will take you out of the AbbVie family of websites. 2022 Aug 27:JCO2201504. Certain medicines must not be taken when you first start taking VENCLEXTA and while your dose is being slowly increased because of the risk of increased TLS. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. AbbVie and SpringWorks will commence the Phase 1 trial in 1H 2022. Mohamed Zaki, M.D., Ph.D., vice president, global head of hematology development, AbbVie. Do you wish to leave this site? Subscribe for email alerts Spotlight. Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. What are the possible side effects of VENCLEXTA? At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners scientists, clinical experts, industry peers, advocates, and patients. As a result of this action, no new patients should be enrolled in any studies of venetoclaxfor multiple myeloma until a further analysis of the data is completed. "Multiple myeloma is one of the most common hematological cancers and an area of significant medical need. Adverse events and change in disease activity will be assessed. Drink plenty of water when taking VENCLEXTA to help reduce your risk of getting TLS. Before engaging, please read and adhere to our established community guidelines for each channel. Durie, M.D., IMF chairman. You are about to leave the AbbVie website. The most commonly occurring adverse reactions (>=20%) of any grade in patients receiving venetoclax in the combination study with rituximab were neutropenia, diarrhea, and upper respiratory tract infection. This landmark retrospective analysis assesses the 16-to-24-percent of myeloma patients harboring the t(11;14) translocation. The path in oncology for Mohamed Zaki, M.D., Ph.D., is one filled with emotional ups and downs. The Foundation's reach extends to more than 525,000 members in 140 countries worldwide. AbbVie has heralded the BCL-2 inhibitor as a key revenue driver for the pharma's post-Humira future. Accessed February 2018. My Journal . One patient was ready to retire to a new family home. AbbVie has informed clinical trial investigators involved in the studies evaluating venetoclax for the treatment of multiple myeloma of the results and will work with them to proceed as appropriate and in the best interest of each patient who may be receiving benefit from venetoclax and who elects to continue receiving treatment. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. AbbVie is committed to responsible data sharing . About VENCLEXTA/VENCLYXTO (venetoclax) Terms of use Navigate Your Myeloma. Sign up Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. Dec 13, 2021 11:56AM EST SpringWorks Therapeutics, Inc. SWTX announced that it is has entered into a clinical study collaboration agreeement with AbbVie ABBV to evaluate a novel combination for. CYP3A4 inducers may decrease VENCLYXTO plasma concentrations. The incremental update shows some progress on working through the clinical hold from March. written authorization of AbbVie Inc., except to identify the product Roland Buelow, CEO of Teneobio, Inc. and TeneoOne, Inc. added, "We are excited to partner with AbbVie on our first clinical candidate, TNB-383B, which targets BCMA using our unique T-cell redirecting platform. Hitting GPRC5D made its first splash as part of a preclinical Juno/Celgene Car-T therapy back at Ash 2018, and though it took a long time for this asset to enter the . Venetoclax is being developed by AbbVie and Roche. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie. In the monotherapy studies, the most common adverse reactions were neutropenia/neutrophil count decreased, diarrhea, nausea, anemia, fatigue, and upper respiratory tract infection. Subscribe for email alerts The most common side effects of VENCLEXTA when used alone in people with CLL/SLLinclude low white blood cell counts; diarrhea; nausea; upper respiratory tract infection; low red blood cell counts; tiredness; low platelet counts; muscle and joint pain; swelling of yourarms, legs, hands, and feet; and cough. TeneoSeek rapidly identifies large numbers of unique binding molecules specific for therapeutic targets of interest. When plasma cells (a type of white blood cell) in the marrow become cancerous, they can grow uncontrollably and produce abnormal proteins (sometimes known as M proteins) and may also cause tumors, typically developing in the bone. 2 Lakshman A, et al. So the indication that was granted was in fifth line plus multiple myeloma, which is very heavily pretreated and frail population. AbbVie https://www.abbvie.com/ Return to Exhibitor Booths Get the latest myeloma news and updates Knowledge is power. The hold remains effective for all other multiple myeloma trials besides CANOVA, with. : AbbVie Inc. View our social media channel guidelines , AbbVie.com Multiple myeloma (MM) is a plasma cell disease characterized by the growth of clonal plasma cells in the bone marrow. Patients with reduced renal function (CrCl <80 mL/min) may require more intensive prophylaxis and monitoring to reduce the risk of TLS. Call: + 1 847-937-4072. Subscription management. No use of any AbbVie trademark, trade name, or trade dress in this site may be made without the prior written authorization of AbbVie Inc., except to identify the product or services of the company. J Clin Oncol. VENCLEXTA is a prescription medicine used: It is not known if VENCLEXTA is safe and effective in children. 2,3 Because of recent technological advances, circulating tumor plasma cells . Tell your healthcare provider right away if you have any symptoms of TLS during treatment with VENCLEXTA, including fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain. Itis important to keep your appointments for blood tests. Serious adverse events of infection were reported in 28.0% of patients in the investigational arm and 27.1% in the control arm. Has had documented disease progression on or within 60 days after completion of the last therapy. If AbbVie exercises its right to acquire TeneoOne, the former stockholders of TeneoOne will also be eligible for regulatory and commercial sales milestones. Teneobio's novel approach to T-cell redirection with TNB-383B has the potential to be a treatment option that may offer new hope for myeloma patients.". Do not start new medicines during treatment with VENCLEXTA without first talking with your healthcare provider. are pregnant or plan to become pregnant. If moderate CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. No use of any AbbVie trademark, trade With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumor types. Abbvie will not be including new multiple myeloma patients in their venetoclax trials, holding off until more data is available in clinical trials. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. A Phase I First-in-Human Study of ABBV-383, a B-Cell Maturation Antigen CD3 Bispecific T-Cell Redirecting Antibody, in Patients With Relapsed/Refractory Multiple Myeloma. CYP3A inhibitors may increase VENCLYXTO plasma concentrations. Cookie Settings. AbbVie Inc is committed to responsible data sharing regarding the clinical trials we sponsor. VENCLYXTO may cause embryo-fetal harm when administered to a pregnant woman. Before engaging, please read and adhere to our established community guidelines for each channel. If you qualify, please, https://www.cancer.org/cancer/multiple-myeloma/about/what-is-multiple-myeloma.html, https://www.cancer.org/cancer/multiple-myeloma/detection-diagnosis-staging/survival-rates.html. The Internet site that you have requested may not be optimized to your screen size. Search. Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. Co-administration of bile acid sequestrants with VENCLYXTO is not recommended as this may reduce the absorption of VENCLYXTO. Copyright 2022 AbbVie Inc. North Chicago, Illinois, U.S.A. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. . Do not breastfeed during treatment with VENCLEXTA. NORTH CHICAGO, Ill., March 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax (VENCLEXTA/VENCLYXTO) for the investigational treatment of multiple myeloma. Documented relapsed or progressive Multiple Myeloma (MM) on or after any regimen or is refractory to the most recent line of therapy. The technology is based on Amgen 's Blincyto (blinatumomab), a treatment for acute lymphoblastic leukemia. Additional analyses are ongoing, and data will be published in a peer-reviewed journal and/or presented at a future medical meeting. The information in the press releases on these pages was factually accurate on the date of publication. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. Before engaging, please read and adhere to our established community guidelines for each channel. Avoid coadministration with strong or moderate CYP3A inducers. But, as recent setbacks have shown, researchers and drugmakers still face major challenges. | AbbVie assumes no duty to update the information to reflect subsequent developments. The information in the press releases on these pages was factually accurate on the date of publication. Practice Pearls Women's Health Zoster. Terms of use Multiple myeloma is a valuable market, but AbbVie's drug hit a major stumbling block this year with a concerning trend in patient deaths from the Phase 3 BELLINI study. Links which take you out of the AbbVie worldwide websites are not under the control of AbbVie, and AbbVie is not responsible for the contents of any such site or any further links from such site. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. Avoid concomitant use of P-gp and BCRP inhibitors at initiation and during the dose titration phase. Serious infections including events of sepsis with fatal outcome have been reported. - Study is among the largest and most comprehensive in multiple myeloma (MM), and will assess outcomes from 1,500 patients with MM and the t(11;14) translocation at participating International Myeloma Foundation sites globally. AbbVie assumes no duty to update the information to reflect subsequent developments. AbbVie is providing these links to you only as a convenience and the inclusion of any link does not imply endorsement of the linked site by AbbVie. At steady daily dose: If moderate or strong CYP3A inhibitors must be used, physicians should refer to the SmPC for dose adjustment recommendations. Changes in electrolytes consistent with TLS that require prompt management can occur as early as 6 to 8 hours following the first dose of VENCLYXTO and at each dose increase. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. You should not drink grapefruit juice or eat grapefruit,Sevilleoranges (often used in marmalades), or starfruit while you are taking VENCLEXTA. ", "Developing novel targeted treatments for patients with cancer continues to be our key priority," said Mohit Trikha, Ph.D., vice president and head, oncology early development, AbbVie. Patients who are currently enrolled in studies and receiving benefit from the therapy may continue with treatment, after consultation with their physician. If you are not sure about the type of immunization or vaccine, ask your healthcare provider. Adults ages 18+ who: - Have multiple myeloma that is not responding to therapy; OR - Have multiple myeloma that has come back after previous therapy - Are positive for a genetic marker called t (11;14) For more information about who can join this study, please contact the study team 919-668-0613. Safety in patients with severe renal impairment (CrCl <30 mL/min) or on dialysis has not been established, and a recommended dose for these patients has not been determined. Forward-Looking StatementsSome statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. or services of the company. Follow@abbvieon Twitter,FacebookorLinkedIn. Cookie Settings. 2VENCLEXTA (venetoclax) [Package Insert]. The incidence of severe, grade 3-5 toxicity (86.5% vs. 87.5%, investigational vs. control arm) and serious adverse events (48.2% vs. 50.0%) was similar between the two arms. AbbVie and SpringWorks will commence the Phase 1 trial in 1H 2022. FDA panel delivers mixed verdict on AstraZenecas asthma drug. Here, Zaki shares his journey working with patients diagnosed with this complicated cancer and explains the continued need for options for relapsing and high-risk patients. BelgiumFRopens in a new window|NLopens in a new window, SwitzerlandDEopens in a new window|FRopens in a new window, CanadaEN opens in a new window|FR opens in a new window. NORTH CHICAGO, Ill. and MENLO PARK, Calif., Feb. 11, 2019 /PRNewswire/ --AbbVie (NYSE: ABBV), Teneobio, Inc. and its affiliate TeneoOne, Inc. announced today that they have entered a global strategic transaction to develop and commercialize TNB-383B, a BCMA-targeting immunotherapeutic for the potential treatment of multiple myeloma. Get the free daily newsletter read by industry experts. VENCLEXTA may cause fertility problems in males. In a pre-planned analysis of the primary endpoint and ranked secondary endpoints, in the venetoclax arm 41 out of 194 (21.1%) deaths were observed, among which, 13 (6.7%) were treatment emergent (HR 2.03, 95% CI [1.042 3.945]). [Epub ahead of print] Keywords provided by TeneoOne Inc.: Additional relevant MeSH terms: To Top VENCLEXTA can cause serious side effects, including: Tumor lysis syndrome (TLS). NORTH CHICAGO, Ill., March 19, 2019 /PRNewswire/ -- AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the U.S. Food and Drug Administration (FDA) has placed a partial clinical hold on all clinical trials evaluating venetoclax (VENCLEXTA/VENCLYXTO) for the investigational treatment of multiple myeloma. 1 Clinicaltrials.gov (2018). This area is reserved for members of the news media. Unless otherwise specified, all product names appearing in this Internet site are trademarks owned by or licensed to AbbVie Inc., its subsidiaries or affiliates. 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Are about to LEAVE for a 3RD PARTY WEBSITE that regulatory action has slowed VENCLEXTA 's progress in myeloma! Adequate hematologic, renal and hepatic function as described in the bone marrow do to. Is contraindicated of pneumonia was 20.7 % in the immune system are also committed to BCL-2 research to. The next five years together, the site may contain information on pharmaceuticals that not Not a complete summary of product characteristics ( SmPC ) at www.ema.europa.eu annual global sales 2025! Plug-And-Play '' T-cell engaging platform includes a abbvie multiple myeloma & Inclusive Workplace, Protecting Human Rights & Workplace safety Providing!: sepsis, pneumonia, and trial-level data ( analysis data technology is based on Amgen & # x27 s Street analysts are n't quite as keen on the sales Potential as AbbVie, please read and adhere our! 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