Targeted Therapy Developed in FCS Clinical Trials Transforming Cancer Treatment For Adult Patients with Diffuse Large B-cell Lymphoma (DLBCL)


A case study details the evolution of a new first-line therapy.

Fort Myers, Fla., April 27, 2023 – Florida Cancer Specialists & Research Institute, LLC (FCS) today released a case study outlining the evolution of a newly FDA-approved first-line therapy for adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The treatment regimen combines use of Polatuzumab Vedotin (POLIVY®), a type of anti-body drug conjugate that is significantly improving outcomes in patients with this aggressive form of lymphoma. FCS actively participated in the phase 1, first in-human monotherapy trial for polatuzumab vedotin, as well as the pivotal phase 3 Polarix study which led to its FDA approval as first-line treatment.

Polatuzumab vedotin was first approved by the U.S. Food & Drug Administration (FDA) in June 2019 for use in combination with two other cancer treatments. The accelerated approval, making the treatment available to all eligible patients, was based on favorable findings from a Phase 1 clinical trial that showed 40% of patients receiving the regimen experienced a disappearance of all signs of cancer and remained in remission for one year or longer.

The FCS Drug Development Unit was one of 13 centers participating in the initial Phase 1 first in-human trial conducted in 2011-2012 to evaluate the drug’s effectiveness. “The observations that we made in this initial trial were the first steps to determining what is now part of standard of care for first line patients,” said Manish R. Patel, MD, FCS Director of Drug Development. “It is rewarding to see the impact of our work in developing this drug.”

Image Credit: Florida Cancer Specialists & Research Institute, LLC

Image Credit: Florida Cancer Specialists & Research Institute, LLC

In August 2022, the FDA accepted a supplemental Biologics License Application for a combination treatment of polatuzumab vedotin and R-CHP for patients with previously untreated DLBCL, based on favorable data from the Phase 3 study. FCS was one of the most active sites during the study, often referred to as the Polarix study, that led to the FDA approval of this first-line treatment.

According to Gustavo Fonseca, MD, FACP, FCS Director of Clinical Research, patients in the Phase 3 study achieved rapid and sustained improvements. “Patients in the study showed improvements in quality of life, functional status and the lymphoma-associated symptoms,” Dr. Fonseca said. “There are other persistent benefits from the patient perspective as well.”

DLBCL accounts for 25 to 30 percent of all blood cancers diagnosed annually in the U.S. and is the most common form of non-Hodgkin lymphoma. The aggressive, fast-growing lymphoma occurs when white blood cells enlarge the lymph nodes; frequently migrating to other organization. Chemotherapy is the most common and effective treatment. The five-year survival rate is 73%.

FCS offers more than 300 clinical trials at three Phase 1 Drug Development Units and 37 clinic locations across Florida. “We remain at the forefront of medical discoveries of new therapies and technologies that are continuing to provide new hope for patients,” said Dr. Fonseca.

Dr. Patel was a co-author of an abstract involving the Phase 1 study assessing the safety and activity of polatuzumab vedotin. Dr. Patel and Dr. Fonseca presented abstracts detailing the breakthrough findings at the American Society of Hematology 64th Annual meeting and Exposition in December 2022.

To read the FCS case study:

To read the study abstracts:

Access the current list of FCS clinical trials:

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About Florida Cancer Specialists & Research Institute, LLC: (
Recognized by the American Society of Clinical Oncology (ASCO) with a national Clinical Trials Participation Award, Florida Cancer Specialists & Research Institute (FCS) offers patients access to more clinical trials than any private oncology practice in Florida. The majority of new cancer drugs recently approved for use in the U.S. were studied in clinical trials with Florida Cancer Specialists participation.* Trained in prestigious medical schools and research institutes, our physicians are consistently ranked nationally as Top Doctors by U.S. News & World Report.

Founded in 1984, Florida Cancer Specialists has built a national reputation for excellence that is reflected in exceptional and compassionate patient care, driven by innovative clinical research, cutting-edge technologies and advanced treatments, including targeted therapies, genomic-based treatment, and immunotherapy. Our highest values are embodied by our outstanding team of highly trained and dedicated physicians, clinicians and staff.

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