FCS Clinical Trials Lead to FDA Approval of New Targeted Drug for Patients with Mantle Cell Lymphoma


In Partnership With

Florida Cancer Specialists

The FDA has approved the first non-covalent Bruton tyrosine kinase inhibitor for the treatment of relapsed or refractory mantle cell lymphoma in adult patients, based on clinical studies conducted with participation by Florida Cancer Specialists & Research Institute.

Fort Myers, Fla., February 14, 2022 – The FDA has approved the first Non-Covalent (Reversible) BTK (Bruton Tyrosine Kinase) inhibitor for the treatment of Relapsed or Refractory Mantle Cell Lymphoma in adult patients, based on clinical studies conducted with participation by Florida Cancer Specialists & Research Institute.

Pirtobrutinib (Jaypirca™) is the first next-generation BTK inhibitor specifically approved by the FDA for adult patients with mantle cell lymphoma (MCL), a rare type of non-Hodgkin’s lymphoma (NHL), which affects about one in 200,000 people worldwide each year. 

“Like several others in the past, it is rewarding to see the impact of our work in developing this drug from the initial trial,” said FCS Director of Drug Development Manish Patel, MD, who oversees early phase clinical studies at the statewide practice.

FCS was one of the first two sites participating in the first cohort of the initial Phase 1 dose trial; with 26 patients enrolled by the FCS Drug Development Unit in Sarasota.

BTK inhibitors for treating MCL were first approved by the FDA in 2013. Administered in pill form, these drugs help to prevent the growth and spread of malignant B lymphocytes, a type of white blood cell located in the outer edge of lymph nodes where MCL frequently begins. As the cancer progresses, it can spread to bone marrow, the spleen, the liver or the digestive tract.

“While these original drugs have proven to be particularly effective in the treatment of MCL and other B-cell hematologic malignances, some patients experience adverse effects and treatment must be discontinued, which negatively impacts their prognosis,” Dr. Patel said. “Pirtobrutinib utilizes a novel binding mechanism. Our clinical studies determined that it offers a significantly improved targeted treatment option, based on overall response rates, progression-free survival and safety.”

Approvals of Pirtobrutinib for the treatment of other types of blood diseases are expected in the future and FCS is actively enrolling patients in Phase III clinical trials of the drug, according to Gustavo A. Fonseca, MD, FACP, FCS Director of Clinical Research. “Many of us feel that this is a best-in-class drug, and we are pleased to utilize our robust clinical research capabilities to further verify and advance this promising new therapy for the benefit of more patients worldwide,” he said.

Dr. Patel is a co-author of multiple abstracts involving Pirtobrutinib for several B cell malignancies and Waldenstrom macroglobulinemia, a rare type of cancer that develops in the white blood cells.

Colleen Lewis, MSN, ANP-BC, AOCNP, Vice President of Nursing & Research said, “With more than 300 clinical trials offered at three Phase 1 Drug Development Units and 37 locations across our practice, we are involved in all phases of breakthrough cancer research that is advancing cancer screening, diagnosis, treatment and survivorship.”

Following an expedited review of the outcomes observed in the BRUIN 18001 study, the FDA granted Pirtobrutinib an accelerated approval. Results were recently presented at the American Society for Hematology Annual Meeting.

To read the full study abstract: https://ash.confex.com/ash/2022/webprogram/Paper157058.html

Access the current list of FCS clinical trials: https://flcancer.com/clinical-trials/


About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
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.

*Prior to approval

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