Groundbreaking New FDA-Approved Drug for Acute Leukemia First Administered at Florida Cancer Specialists & Research Institute Sarasota Drug Development Unit

Fort Myers, Fla., November 22, 2024 – A landmark in cancer treatment has come full circle, as the U.S. Food and Drug Administration (FDA) approved revumenib, a revolutionary drug for relapsed or refractory acute leukemia with a KMT2A translocation on November 15, 2024. This life-saving therapy, first administered to a Florida Cancer Specialists & Research Institute, LLC (FCS) patient at its Sarasota Drug Development Unit (DDU) in 2019 as part of a Phase 1 clinical trial, is now available to patients nationwide.

The very first patient to ever receive this groundbreaking treatment was referred by FCS medical oncologist/hematologist Muhammad Imam, MD to FCS Director of Drug Development Manish R. Patel, MD at the FCS Sarasota DDU, one of three early-phase clinical trial sites within the statewide practice. This milestone underscores FCS’ fundamental role in the development of this drug, which has now gained FDA approval for its remarkable ability to target and treat MLL-rearranged leukemia.

“This latest FDA approval of revumenib is a testament to the power of innovation and collaboration—values deeply embedded in our practice’s history,” said FCS President & Managing Physician Lucio N. Gordan, MD. “Since treating the first patient in 2019, we’ve believed in the transformative potential of this therapy for leukemia patients. It’s moments like these that affirm our longstanding commitment to advancing oncology care through research. This milestone not only validates that belief but also brings hope to countless individuals facing this devastating disease, reflecting the unwavering dedication of our team to improving lives.”

Acute myeloid leukemia (AML) and acute lymphoblastic leukemia (ALL) are rare and aggressive blood cancers often resistant to standard treatments. This new drug, specifically designed to target the genetic abnormalities driving the disease, has demonstrated exceptional efficacy in clinical trials, significantly improving remission rates and overall survival.

Dr. Patel, the principal investigator for the clinical trial at FCS, shared his perspective on the approval: “Conducting this trial was an extraordinary scientific and clinical journey. We observed firsthand the profound impact this therapy had on patients who previously faced limited treatment options. The FDA’s approval represents the culmination of years of rigorous research, collaborative effort, and the unwavering commitment of our team. Most importantly, it honors the bravery of the patients who participated and trusted us to pursue this innovative approach.”

FCS played a critical role in the clinical trial phase of the drug’s development, working in collaboration with Sarah Cannon Research Institute. The FDA’s approval represents years of dedicated effort from the global medical and scientific communities.

With three early-phase drug development sites and 30 late-phase locations across Florida, FCS boasts one of the nation’s most extensive oncology research programs. Patients benefit from access to over 180 clinical trials at any given time, with more than 600 individuals receiving cutting-edge treatments annually. Notably, the majority of new cancer drugs recently approved for use in the U.S. underwent clinical trials involving FCS’ participation before gaining approval.

Related Abstracts:

The menin inhibitor revumenib in KMT2A-rearranged or NPM1-mutant leukaemia (March 15, 2023)

The Menin Inhibitor SNDX-5613 (revumenib) Leads to Durable Responses in Patients (Pts) with KMT2A-Rearranged or NPM1 Mutant AML: Updated Results of a Phase (Ph) 1 Study (November 15, 2022)