Teclistamab

As a BCMA-targeting CAR T-cell therapy, CARVYKTI addresses a high unmet need in relapsed or refractory multiple myeloma patients. With promising clinical efficacy, durable responses, and growing adoption in advanced treatment lines, CARVYKTI is poised for substantial revenue growth. LAS VEGAS, March 24, 2025 /PRNewswire/ -- DelveInsight's " CARVYKTI Market Size, Forecast, and Market Insight Report" highlights the details around CARVYKTI, a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient's T cells with a transgene encoding a CAR that identifies and eliminates cells that express BCMA. The report provides product descriptions, patent details, and competitor products (marketed and emerging therapies) of CARVYKTI. The report also highlights the historical and forecasted sales from 2020 to 2034 segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Janssen's CARVYKTI (ciltacabtagene autoleucel) Overview CARVYKTI is an autologous T-cell immunotherapy that targets B-cell maturation antigen (BCMA). It works by genetically modifying a patient's T cells with a transgene that encodes a chimeric antigen receptor (CAR). This CAR helps the T cells recognize and destroy cells expressing BCMA, which is primarily found in malignant multiple myeloma B-lineage cells, late-stage B cells, and plasma cells. The CARVYKTI CAR protein includes two single-domain antibodies designed to bind strongly to human BCMA, enhancing T-cell activation, proliferation, and the destruction of target cells upon binding. Currently, CAR-T cell therapies are only available to UK patients through clinical trials. Janssen recently decided not to proceed with seeking approval for cilta-cel (CARVYKTI) for myeloma patients in the UK through the National Institute for Health and Care Excellence (NICE). This decision means cilta-cel will not be available on the NHS for now, although it remains accessible through clinical trials. Janssen's decision does not impact ongoing trials. The drug is currently being evaluated in Phase III trials: CARTITUDE-6 for frontline multiple myeloma transplant eligible vs ASCT and CARTITUDE-5 for frontline multiple myeloma TNI. In 2024, CARVYKTI generated sales of USD 963 million across the world. CARVYKTI Dosage and Administration CARVYKTI is administered as a single infusion containing a suspension of CAR-positive, viable T cells in one infusion bag. The recommended dosage ranges from 0.5 to 1.0 × 10⁶ CAR-positive viable T cells per kilogram of body weight, with a maximum limit of 1 × 10⁸ CAR-positive viable T cells per infusion. Learn more about CARVYKTI projected market size for multiple myeloma @ CARVYKTI Market Potential CAR-T cell immunotherapy is emerging as a revolutionary treatment for multiple myeloma, offering new hope to patients who have exhausted conventional treatment options. Currently, only two CAR-T cell therapies are approved for multiple myeloma: ABECMA (idecabtagene vicleucel) from Bristol-Myers Squibb and CARVYKTI (ciltacabtagene autoleucel) from Johnson & Johnson Innovative Medicine. Their approval highlights the potential of CAR-T therapy to transform multiple myeloma treatment. A key advantage of CAR-T therapies is their "one-and-done" nature, requiring a single administration, unlike bispecific antibodies such as TECVAYLI and TALVEY, which need ongoing dosing. Present CAR-T therapies use a patient's own T cells (autologous), but research is underway to develop allogeneic CAR-T cells derived from healthy donors. Allogeneic therapies could offer off-the-shelf solutions, enhancing accessibility and lowering costs. The approval of CAR-T therapies has created new opportunities for companies focused on advanced-stage multiple myeloma (fourth line and beyond). Several companies are progressing with their CAR-T candidates at different stages of development. The CAR-T cell therapy market for multiple myeloma is expected to grow significantly between 2024 and 2034, driven by its high efficacy and potential for expanded use. Collaboration between pharmaceutical companies and research institutions, along with ongoing innovation, is expected to accelerate market growth. However, challenges such as manufacturing complexity and pricing will need to be addressed to unlock the full potential of CAR-T therapies. Discover more about the CAR T-cell therapy for multiple myeloma market in detail @ CAR T-cell Therapy for Multiple Myeloma Market Report Emerging Competitors of CARVYKTI Some of the CAR-Ts in the multiple myeloma pipeline that will give fierce competition to CARVYKTI include Anito-cel (Arcellx), PHE885 (Novartis), BMS-986393 (Bristol-Myers Squibb), Zevorcabtagene Autoleucel (CARsgen Therapeutics), and GLPG5301 (Galapagos), among others In December 2024, Arcellx announced encouraging new data from its Phase II pivotal iMMagine-1 trial for anito-cel in multiple myeloma. The results were presented during an oral session at the 66th American Society of Hematology (ASH) Annual Meeting on Monday, December 9, 2024, at 5:30 p.m. PT. Also at ASH 2024, BMS shared the first overall survival (OS) and progression-free survival (PFS) results for arlo-cel in an oral presentation. The Phase I trial involved patients with relapsed or refractory multiple myeloma who had previously undergone at least three treatments, including a proteasome inhibitor, an immunomodulatory drug, and anti-CD38 therapy. Among 79 patients evaluable for efficacy, with a median follow-up of 16.1 months (range: 2.8–25.2), arlo-cel showed an overall response rate (ORR) of 87%, indicating durable responses. Minimal residual disease (MRD) was assessed as an exploratory measure, with 57% (48 of 84) of MRD-evaluable patients included. Of these, 46% (22 of 48) were MRD-negative and achieved a complete response (CR) or stringent CR (sCR). Across all treated patients, 27% (23 of 84) were MRD-negative and achieved a CR. Median PFS was 18.3 months (95% CI: 11.8–21.9), while the median OS had not yet been reached. To know more about the number of competing drugs in development, visit @ CARVYKTI Market Positioning Compared to Other Drugs Key Milestones of CARVYKTI In April 2024, Johnson & Johnson announced that the US FDA approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide. In March 2024, Johnson & Johnson announced that the US FDA Oncologic Drugs Advisory Committee (ODAC) recommends CARVYKTI for the treatment of adult patients with RRMM who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) and who are refractory to lenalidomide. In February 2024, Johnson & Johnson announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of a Type II variation for CARVYKTI for the earlier treatment of RRMM. In September 2022, Legend Biotech announced that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved CARVYKTI (ciltacabtagene autoleucel) for the treatment of adults with relapsed or refractory multiple myeloma, limited to cases meeting both of the following conditions including patients having no history of CAR-positive T-cell infusion therapy targeting BCMA and patients who have received three or more lines of therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 monoclonal antibody, and in whom multiple myeloma has not responded to or has relapsed following the most recent therapy. In May 2022, Janssen announced that the European Commission (EC) granted conditional marketing authorization for CARVYKTI for the treatment of adults with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI) and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. In February 2022, Janssen announced that the US FDA had approved CARVYKTI (ciltacabtagene autoleucel; cilta-cel) for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. In August 2020, Legend Biotech announced that the China Center for Drug Evaluation, National Medical Products Administration (CDE, NMPA) had recommended BTD for ciltacabtagene autoleucel (cilta-cel; LCAR-B38M CAR-T cells) for the treatment of adults with relapsed or refractory multiple myeloma. In December 2019, Janssen announced receipt of a BTD from the US FDA for cilta-cel. In April 2019, the EMA granted a PRIME (PRIority MEdicines) designation for the company's investigational BCMA CAR-T therapy. In February 2019, the US FDA granted ODD for cilta-cel (JNJ-4528), and in February 2020, the European Commission also granted orphan designation for this drug. In December 2017, Janssen entered a worldwide collaboration and license agreement with Legend Biotech to jointly develop and commercialize LCAR-B38M in multiple myeloma Discover how CARVYKTI is shaping the multiple myeloma treatment landscape @ CARVYKTI CAR-T CARVYKTI Market Dynamics The market for CARVYKTI is driven by the increasing prevalence of multiple myeloma and the growing demand for innovative therapies that can address the limitations of existing treatments, such as proteasome inhibitors and immunomodulatory drugs. The competitive landscape includes other BCMA-targeting therapies, such as Bristol Myers Squibb's ABECMA (idecabtagene vicleucel), which was the first BCMA-directed CAR-T therapy approved for multiple myeloma. CARVYKTI's strong clinical efficacy, coupled with its potential for long-term remission, gives it a competitive edge, but challenges related to manufacturing scalability, logistical complexities, and high treatment costs could impact its market penetration and patient accessibility. Strategic partnerships and ongoing clinical development will play a key role in expanding CARVYKTI's market reach. Janssen and Legend Biotech are actively working to improve manufacturing processes to reduce vein-to-vein time and address supply chain bottlenecks. Furthermore, ongoing trials, such as CARTITUDE-4, are exploring CARVYKTI's use in earlier lines of therapy, which could significantly expand its patient base and market potential. If successful in earlier settings, CARVYKTI could shift the treatment paradigm for multiple myeloma and increase adoption among physicians and healthcare providers. Despite its promising clinical profile, CARVYKTI faces challenges related to reimbursement and healthcare infrastructure. The high cost of CAR-T therapies often limits patient access, particularly in markets with strict reimbursement policies. Moreover, the complex nature of CAR-T administration, which requires specialized centers and trained personnel, adds to the barriers. However, continued clinical success, regulatory support, and improvements in manufacturing and delivery infrastructure could strengthen CARVYKTI's market position and establish it as a cornerstone therapy in the multiple myeloma treatment landscape. Dive deeper to get more insight into CARVYKTI's strengths & weaknesses relative to competitors @ CARVYKTI Market Drug Report Table of Contents Related Reports Relapsing Refractory Multiple Myeloma Market Relapsing Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key RRMM companies including AbbVie, Genentech, Amgen, Onyx Therapeutics Inc., Bristol-Myers Squibb, MedImmune LLC, Novartis Pharmaceuticals, Incyte Corporation, Takeda, among others. Relapsing Refractory Multiple Myeloma Pipeline Relapsing Refractory Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key RRMM companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. Multiple Myeloma Market Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies including Sanofi, Karyopharm Therapeutics, AbbVie, Takeda Pharmaceutical, Celgene, Bristol-Myers Squibb, RAPA Therapeutics, Pfizer, Array Biopharma, Cellectar Biosciences, BioLineRx, Celgene, Aduro Biotech, ExCellThera, Janssen Pharmaceutical, Precision BioSciences, Takeda, Glenmark (Ichnos Sciences SA), Poseida Therapeutics, Molecular Partners AG, Chipscreen Biosciences, AbbVie, Genentech (Roche), Janssen Biotech, Nanjing Legend Biotech, Merck Sharp & Dohme Corp., among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including CASI Pharmaceuticals, Carsgen Therapeutics, Cartesian Therapeutics, Gracell Biotechnology Shanghai Co., Ltd., Sorrento Therapeutics, TeneoOne, Karyopharma Therapeutics, Arcellx, Poseida Therapeutics, Ichnos Sciences, Nerviano Medical Sciences, Bristol Myers Squib, Ascentage Pharma, Ionis Pharmaceuticals, Chongqing Precision Biotech Co., Ltd., CRISPR Therapeutics, AstraZeneca, IGM Biosciences, Novartis, GlaxoSmithKline, Innovent Biologics, Keymed Biociences, Starton Therapeutics, Takeda, Fate Therapeutics, Gilead Sciences, Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd., Janssen Pharmaceutical, Nanjing IASO Biotechnology Co., Ltd., GPCR Therapeutics, Chimerix, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Dr. Tendler oversaw 30 Major Drug Approvals, including worldwide approvals for J&J’s transformational treatments in hematologic malignancies, prostate, lung and bladder cancers Dr. Tendler also oversaw 13 FDA Breakthrough Designations accelerating the early development of promising investigational medicines intended for treatment of serious oncology indications TAMPA, FL / ACCESS Newswire / March 11, 2025 / TuHURA Biosciences, Inc. (NASDAQ:HURA) (“TuHURA”), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced it has appointed Craig L. Tendler, M.D. to its Board of Directors effective March 10, 2025. “We are honored and thrilled to have Craig join our Board of Directors. His extensive experience in creating and overseeing development plans, including integration of biomarkers and diagnostics and overseeing comprehensive data-generation activities for all products in the oncology portfolio while at J&J, from proof of concept through registration and lifecycle management, will be a valuable asset to TuHURA as we advance IFx-2.0 through its registrational Phase 3 clinical trial planned to begin in second quarter 2025 and while we pursue optimal positioning of our pipeline of novel therapeutics focused on overcoming resistance to cancer immunotherapy,” commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. “His experience in overseeing major oncology business development opportunities, culminating in the acquisition/co-development of practice-changing oncology products, will be valuable in assisting the Company in evaluating potential corporate collaborations and potential acquisitions of other novel therapeutics to add to the Company’s pipeline.” “His impressive track record achieving worldwide approvals for transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA), will supplement the Board’s broad expertise with proven results across all aspects of oncology drug development at a critical juncture in TuHURA’s development programs,” noted James Manuso, Ph.D., Chairman of TuHURA’s Board of Directors. Dr. Tendler added, “TuHURA has established a science-based portfolio of novel complementary technologies and late-stage drug candidates that I believe has the potential to make a significant impact on the immuno-oncology treatment landscape. The data demonstrated to date are promising and underscore the ability of one of their potential therapeutics, IFx-2.0, to overcome resistance to immune checkpoint inhibitor therapy, a much-needed advance to further the patient benefit of this important class of cancer immuno-therapeutics. With their recent agreement with Kineta to acquire its VISTA inhibiting antibody, leveraging their novel discovery of the critical role the delta opioid receptor may play in controlling the immune suppressing capabilities of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages, I feel this is an optimal time to bring my experience in oncology drug development to the Board and to management. I look forward to contributing to the continued growth and future success of the Company.” Dr. Tendler previously served as Vice President, Oncology Clinical Development, Diagnostics, and Global Medical Affairs of Johnson & Johnson Innovative Medicine Research & Development (Retired). In this position, he was responsible for creating and overseeing robust development plans, including optimal integration of biomarkers and diagnostics, and comprehensive data generation activities for all products in the oncology portfolio, from proof of concept through registration and lifecycle management. He worked closely with teams in early development and the disease areas of focus to implement a seamless end-to-end oncology clinical research strategy that incorporated compelling science, broad clinical trial access to diverse populations, and addressed areas of high unmet medical need. During his tenure at Johnson & Johnson, Dr. Tendler and his team worked in collaboration with the FDA and the European Medicines Agency to secure the worldwide approvals of transformational treatments in prostate cancer (ZYTIGA, AKEEGA, and ERLEADA), hematologic malignancies (DARZALEX, CARVYKTI, TECVAYLI, TALVEY, IMBRUVICA), as well as for lung (RYBREVANT) and bladder cancer (BALVERSA). He has played an instrumental role in achieving 13 FDA breakthrough designations for accelerating the early development of promising investigational medicines intended for the treatment of serious oncology conditions. Prior to joining Johnson & Johnson Innovative Medicine, Craig served as the Vice President of Oncology Clinical Research and Chair of the Oncology Licensing Committee at the Schering-Plough Research Institute. In addition to his pharmaceutical industry experience, Craig has served as Co-Chair of the Friends of Cancer Research Corporate Council, member of the Bloomberg New Economy International Cancer Coalition, and member of the Admissions Committee, Mount Sinai School of Medicine. He was an Assistant Professor of Pediatrics/Hematology-Oncology at the Mount Sinai School of Medicine and a NIH physician-scientist grant recipient and research fellow at the National Cancer Institute in Bethesda, Maryland. Dr. Tendler earned his undergraduate degree from Cornell University, and graduated from the Mount Sinai School of Medicine, New York City, with high honors and induction into the Alpha Omega Alpha Medical Society. About TuHURA Biosciences, Inc. TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer. TuHURA’s lead innate immune agonist drug candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate in the second quarter 2025, a single randomized placebo-controlled Phase 3 registration=directed trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® and placebo in first-line treatment for advanced or metastatic Merkel Cell Carcinoma. In addition to its innate immune agonist candidates, following the closing of the previously announced proposed merger with Kineta, TuHURA plans to advance its VISTA inhibiting antibody into a phase two trial in combination with a menin inhibitor in NPM1 mutated relapsed or refractory AML. Leveraging its discovery of the central role the Delta Opioid Receptor plays in modulating the immunosuppressive effects of myeloid derived suppressor cells (MDSCs) and tumor associated M2 polarized macrophages on the tumor microenvironment (TME), the Company is also developing non-tumor targeting ADCs and APCs to convert the TME to an immunogenic phenotype, potentially overcoming acquired resistance to checkpoint inhibitors and cellular therapies. For more information, please visit tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn. Forward-Looking Statements This press release contains certain “forward-looking statements” within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “should,” “would,” “project,” “plan,” “expect,” “goal,” “seek,” “future,” “likely” or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA’s expectations, hopes, beliefs, intentions or strategies regarding the future including, without limitation, statements regarding clinical trials and research and development programs, in particular with respect to TuHURA’s IFx-Hu2.0 product candidate and its ADC and PDC development program, and any developments or results in connection therewith. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company’s website, and at www.sec.gov. You are cautioned that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from those set forth in the forward-looking statements. The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities. Investor Contact: JTC Team, LLCJenene Thomas(908) 824-0775tuhura@jtcir.com SOURCE: TuHURA Biosciences, Inc. View the original press release on ACCESS Newswire