Belantamab mafodotin

FORT MYERS, Fla., Dec. 3, 2025 /PRNewswire/ -- Results of eleven research studies conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) were selected for presentation at the American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando. The gathering is regarded as the leading global meeting for top researchers and clinicians driving innovation in the treatment of blood cancers and blood disorders. "Our commitment to discovery has yielded significant milestones in advancing the next generation of therapies for blood cancers and other hematologic conditions," said FCS President & Managing Physician Lucio N. Gordan, MD. One of the nation's most extensive community-based oncology research programs, FCS provides access to advanced clinical trials across 29 locations in Florida, including three early-phase drug development units (DDUs). The majority of new cancer drugs approved in recent years for use in the U.S. underwent clinical trials involving FCS participation before gaining approval. FCS was one of the initial two sites involved in the Phase 1 trial of pirtobrutinib, now regarded as a best-in-class targeted therapy for several blood cancers and the first next-generation BTK inhibitor approved by the U.S. Food & Drug Administration (FDA) in 2023 for mantle cell lymphoma (MCL), followed shortly by approvals for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). In 2024, the FDA approved revumenib—a revolutionary therapy for relapsed or refractory acute leukemia—after it was first administered to an FCS patient. Manish Patel, MD, FCS Director of Drug Development, has co-authored several abstracts on pirtobrutinib, including two selected for presentation at the ASH annual meeting: Pirtobrutinib in Relapsed/Refractory (R/R) Waldenström macroglobulinemia (WM): Up to 5 years of follow-up from the Phase 1/2 BRUIN study Pirtobrutinib in post-cbtki CLL/SLL: Final update from the Phase 1/2 BRUIN study with more than 5 years follow-up Additionally, the following FCS hematologists and medical oncologists are co-authors of abstracts that will be presented in oral or poster presentations: Gustavo Fonseca, MD, FACP, FCS Director of Research & Clinical Trials ANKRD26-related thrombocytopenia: Hematologic malignancy characteristics, clinical outcomes, and precursor states Asciminib (ASC) in chronic myeloid leukemia in chronic Phase (CML-CP): Interim analysis (IA) efficacy and safety results of the Phase 2 ASC2ESCALATE trial in the cohort of newly diagnosed (1L) patients (pts) Shachar Peles, MD, FCS Director of Cell Therapy Fixed treatment duration subcutaneous mosunetuzumab monotherapy in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma: Interim results from the Phase II MorningSun study Jeffrey Bubis, DO, FACOI, FACP Optimizing processes for adverse event management for bispecific antibodies for diffuse large b-cell lymphoma in community practice: Insights from a quality improvement initiative Jennifer Cultrera, MD Zanubrutinib is well tolerated and effective in acalabrutinib-intolerant patients with B-cell malignancies: A long-term follow-up Uma Iyer, MD Evaluating the effect of morbid obesity on DVT in patients already on doac therapy: A retrospective analysis Mahender Yellu, MD, MBBS, MHA Nationwide impact of CAR-T approval on acute lymphoblastic leukemia mortality in the United States, 1999-2023: Difference-in-differences and synthetic control analyses Syed Zafar, MD: Deep responses and durable outcomes in patients treated with belantamab mafodotin plus pomalidomide and dexamethasone from long-term follow-up of the Phase 3 dreamm-8 study Functional high-risk relapsed/refractory multiple myeloma (RRMM) outcomes with belantamab mafodotin (belamaf): Dreamm-7 and dreamm-8 subgroup analysis A comprehensive list of abstracts presented at the 2025 ASH Annual Meeting and Exposition can be found here: ASH Annual Meeting Abstracts. Over 110 new early-phase and 40 late-phase studies are launched annually at FCS in partnership with Sarah Cannon Research Institute (SCRI), one of the world's leading oncology research organizations conducting community-based clinical trials. Additionally, a partnership with Paradigm Health, Inc. aids in streamlining and accelerating patient matching to available clinical trials. To learn more about clinical trials offered at FCS, visit: About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com) For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program. FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. In fact, before receiving FDA approval, the majority of new cancer drugs in the U.S. were first made available to patients through participation in clinical trials at FCS. Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes. SOURCE Florida Cancer Specialists & Research Institute 21% more press release views with Request a Demo

iStock, Sundry Photography Darzalex Faspro’s approval for smoldering multiple myeloma could allow for earlier intervention and reduce the risk of progression to active disease. The FDA has signed off on Johnson & Johnson’s oncology blockbuster Darzalex Faspro for smoldering multiple myeloma, marking the first approved therapy for the indication. The approval indicates Darzalex Faspro for high-risk adult patients, who according to J&J, are more likely to progress to active disease within two years of being diagnosed. The expansion of Darzalex Faspro enables “earlier intervention and disease interception,” the pharma said on Thursday. The approval is backed by data from the Phase III AQUILA study , which enrolled nearly 400 patients and compared Darzalex Faspro intervention to active monitoring, also known as the watch and wait approach to surveillance. Results presented in December last year showed that the drug was able to significantly delay disease progression to active multiple myeloma, resulting in an overall 51% benefit versus active monitoring. This effect was more pronounced in those who were classified as high-risk, with Darzalex Faspro’s benefit reaching 64%. Treatment also improved overall survival by 48%. In May this year, the FDA’s Oncologic Drugs Advisory Committee voted 6–2 in favor of approving Darzalex Faspro for high-risk smoldering multiple myeloma. Administered under the skin, Darzalex Faspro is a monoclonal antibody designed to bind the CD38 protein, which is found on certain subsets of cells involved in the pathology of multiple myeloma. This mechanism of action allows Darzalex Faspro to block the growth of cancer cells and trigger their death. The drug is also approved for various types of multiple myeloma and light chain amyloidosis. Since first winning the FDA’s blessing in 2020, Darzalex Faspro has become one of J&J’s most valuable franchises. Last year, the product brought in more than $11.6 billion worldwide, accounting for more than half of the pharma’s cancer earnings. In the third quarter of this year, Darzalex Faspro emerged as J&J’s top-selling drug, hitting more than $3.6 billion in sales —nearly a 20% year-on-year growth. Darzalex Faspro’s label expansion on Thursday is the second bit of news for the multiple myeloma space in recent weeks. Late last month, the FDA allowed the comeback of GSK’s antibody-drug conjugate Blenrep, clearing its use for third-line multiple myeloma. That approval came despite an overwhelmingly negative adcomm vote in July. “The efficacy data were strong but the toxicity data were also very strong,” Neil Vasan, expert panelist and assistant professor at the Columbia University Medical Center, said during the committee meeting. Vasan voted against Blenrep’s approval.