Innovating Cancer Care: Find Hope in Clinical Trials
A Groundbreaking Year for Clinical Research
Florida Cancer Specialists & Research Institute (FCS) achieved double-digit growth in early-phase clinical trials conducted at its three Drug Development Units (DDUs) in 2024. This milestone highlights FCS’ commitment to advancing cancer care and developing transformational therapies at the earliest phases of research.
Unparalleled Leadership in Phase 1 Clinical Trials
By comparison, FCS patients have access to more Phase 1 clinical trials than patients in most academic medical centers nationwide, with DDUs located in Sarasota and Central Florida. These state-of-the-art facilities focus exclusively on early-phase research, playing a fundamental role in uncovering innovative cancer treatments. In 2024 alone, participation in Phase 1 clinical trials grew by 14% across a diverse range of studies. For instance, numerous immunotherapy clinical trials have yielded critical insights into the body’s ability to recognize, prevent, and combat cancer cells.
“Advancing innovative treatment options for all forms of cancer and blood disorders is at the core of our mission,” said FCS President & Managing Physician Lucio N. Gordan, MD. “We are continuously delivering on our promise to provide as many cancer patients as possible with opportunities to participate in lifesaving clinical trials close to home.”
Pioneering Therapies and FDA Approvals
FCS has played a vital role in the development of numerous cancer drugs approved by the U.S. Food and Drug Administration (FDA). Many of these therapies began as Phase 1 or first-in-human clinical trials at FCS DDUs. For instance, revumenib, a revolutionary drug for relapsed or refractory acute leukemia, was first administered to a patient at the FCS Sarasota DDU in 2019 as part of a Phase 1 trial. This breakthrough drug received FDA approval in November 2024 and is now available to patients nationwide.
Another standout achievement was FCS’ participation in the initial Phase 1 dose trial for pirtobrutinib. This targeted treatment for a rare type of non-Hodgkin’s lymphoma has since been recognized as a best-in-class therapy for patients resistant to traditional treatments.
A recent FCS case study outlines another successful therapy for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), polatuzumab vedotin, that began as a Phase 1, first-in-human trial at its Sarasota DDU. The findings from early-phase clinical trials led to its accelerated FDA approval in 2019. Later, in August 2022, the FDA accepted a supplemental Biologics License Application (sBLA) for a combination therapy involving polatuzumab vedotin following results from a late-phase trial in which FCS was a participant.
“These milestones underscore our fundamental role in the development of novel treatments for an expanding list of cancer types,” said the FCS Director of Drug Development Manish R. Patel, MD, a principal investigator on numerous oncology and hematology early-phase clinical trials, as well as a noted oncology expert and frequent presenter at international symposiums.
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Expanding Access to Lifesaving Treatments
FCS provides access to advanced clinical trial options, both in early and late-phase, across 29 locations in Florida, bringing promising therapies closer to home for cancer patients. Currently, more than 500 patients are participating in trials spanning all phases, with over 110 new early-phase and 40 late-phase studies launched annually.
“We continue to expand and enhance our clinical capabilities, resources, and partnerships to conduct trials more effectively and bring potentially life-saving therapies to more patients faster,” said Nathan H. Walcker, FCS Chief Executive Officer. “Best of all, patients in our statewide practice can access the most promising treatments in a comfortable, familiar setting with their trusted care team.”
Most recently, the FCS Disease Site Committee was established to address the unique challenges associated with specific cancer types. Already, the committee has identified eight specialties of focus: breast, gastrointestinal (GI), genitourinary (GU), gynecologic (GYN) and other, head and neck, hematology, skin and thoracic.
Strategic Partnerships Fueling Innovation
FCS’s longstanding collaboration with the Sarah Cannon Research Institute (SCRI) has been a cornerstone of its success. This partnership connects FCS to a network that reaches more clinical trial patients than any single cancer center in Florida, ensuring access to cutting-edge trials and integrating research into patient care.
Additionally, FCS recently partnered with Paradigm Health, Inc. (Paradigm) to further enhance patient access to clinical trials. By leveraging advanced electronic medical records, genomics, real-world evidence data, and Paradigm’s AI-driven technology platform, FCS has streamlined the process of screening patients for trial eligibility, making participation more efficient and accessible.
The Road Ahead
As FCS celebrates its growth in early-phase clinical trials, the organization remains steadfast in its mission to transform oncology care. By fostering innovation, building strategic partnerships, and prioritizing patient-centered care, FCS is at the forefront of delivering groundbreaking therapies to patients across Florida and beyond.
To learn more about FCS’s clinical trials and their impact on cancer treatment, visit https://flcancer.com/participating-in-a-clinical-trial/.
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