FCS Contributes to Two Significant FDA Approvals Advancing Breast and Pancreatic Cancer Care

FCS Clinical Research Continues to Pave the Way for Breakthrough Treatments

Fort Myers, Fla., October 14, 2026 – Florida Cancer Specialists & Research Institute, LLC (FCS) is celebrating its pivotal role in the development of two recently approved targeted therapies that expand treatment options for patients with advanced breast and pancreatic cancers, underscoring the FCS’s longstanding commitment to advancing oncology research and expanding access to clinical trials.

“These approvals follow years of clinical research with FCS participation and highlight the vital role of clinical trials in translating scientific discoveries into meaningful treatment advances for patients,” said FCS President & Managing Physician Lucio N. Gordan, MD.

The U.S. Food and Drug Administration (FDA) recently granted accelerated approval to camizestrant, in combination with a CDK4/6 inhibitor, for certain adult patients with hormone receptor-positive (HR-positive), HER2-negative breast cancer whose tumors develop an ESR1 mutation during treatment and make some breast cancers resistant to hormone therapy. Camizestrant is an oral selective estrogen receptor degrader (SERD) that blocks estrogen signaling, while CDK4/6 inhibitors help prevent cancer cells from growing and dividing. This combination of camizestrant and CDK4/6 inhibitors provide a complementary approach to overcoming treatment resistance.

Camizestrant’s first-in-human Phase 1 dose-escalation study was conducted at the FCS Sarasota Drug Development Unit (DDU) in 2019, helping support the drug’s early clinical development. FCS later participated in Phase 3 trials that further evaluated the therapy, and helped produce results demonstrating that patients who switched to camizestrant achieved a median progression-free survival nearly twice that of patients in the control group.

The FDA also recently approved daraxonrasib, a targeted therapy for certain adult patients with metastatic pancreatic cancer, marking an important advancement for a disease that has historically had limited treatment options and poor survival outcomes.

FCS contributed to the development of daraxonrasib through participation in early-phase clinical trials that helped generate data to evaluate the therapy’s safety and potential effectiveness, informing subsequent studies that supported FDA approval. In the pivotal trial supporting approval, patients treated with daraxonrasib had median overall survival of 13.2 months compared with 6.7 months for patients who received standard-of-care chemotherapy.

Manish R. Patel, MD, FCS medical director of drug development, said, “These targeted therapies add to the growing list of FDA-approved drugs that began as Phase 1 or first-in-human clinical trials at our drug development units and are helping provide new options for patients with many forms of cancer and blood disorders.” In the past decade, the majority of new cancer drugs approved for use in the U.S. were studied in clinical trials with FCS participation.

“These approvals are important examples of how research can help expand treatment options for patients,” added Amanda Olson, MD, FCS medical director of late-phase clinical research. “FCS remains actively engaged in ongoing studies exploring additional potential applications for approved and investigational therapies in pancreatic cancer, breast cancer and other tumor types,” she added.

As one of the nation’s leading community oncology research programs, FCS continues to provide patients access to innovative clinical trials while helping bring the next generation of cancer treatments from the research setting to routine clinical practice. Through partnerships with Sarah Cannon Research Institute (SCRI)—one of the world’s leading oncology research organizations conducting community-based clinical trials—and Paradigm, Inc., FCS offers convenient access to clinical trials at nearly 30 locations statewide, including early-phase studies at Drug Development Units in Sarasota and Central Florida.

FCS Vice President of Clinical Research Kim Vigal, MPH said, “From first-in-human studies to later-phase clinical trials, FCS is proud to help advance promising therapies that may improve outcomes and expand treatment options for patients today and in the future.”

To learn more: FLCancer.com