- FDA approved Rasonque for certain adults with metastatic pancreatic adenocarcinoma after a clinical trial showed the drug nearly doubled median overall survival compared with standard chemotherapy.
- Memorial Cancer Institute is the first cancer program in Broward County, Florida to obtain daraxonrasib, a drug representing one of the most significant breakthroughs in pancreatic cancer treatment in decades.
- The FDA had issued a “safe to proceed” letter in May allowing Revolution Medicines to initiate an expanded-access treatment protocol, providing qualifying patients access to the investigational drug before its approval under applicable federal regulations.
- Russell Reed was diagnosed with Stage 2B pancreatic cancer in 2024 and became the first patient at Memorial Cancer Institute to receive daraxonrasib through the FDA's Expanded Access program in July 2026.
The FDA's approval of Rasonque, also known as daraxonrasib, marks a significant advancement in the treatment of metastatic pancreatic adenocarcinoma, a notoriously difficult cancer to treat.
Angelo de Claro, director of the FDA’s Oncology Center of Excellence, noted, “This drug showed unprecedented results in an area of high unmet need.”
The approval, which came 6.5 months ahead of the user-fee deadline, followed an expedited review process that included Breakthrough Therapy and Orphan Drug designations.
“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” stated Kyle Diamantas, Acting FDA Commissioner.
Rasonque is approved for adults who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.
In a clinical trial involving 500 adults, patients receiving Rasonque had a median overall survival of 13.2 months, compared to 6.7 months for those on standard chemotherapy.
Memorial Cancer Institute, the first in Broward County to acquire the drug, previously provided access through the FDA's Expanded Access program.2
Dr. Jesus Fabregas, who led the effort, emphasized the drug's potential, stating, “It’s not a cure, but it’s a big step for humanity. Patients live longer, have a better quality of life, less pain, and more happy times with family and friends.”
Russell Reed, a patient at Memorial, expressed hope for pain relief, stating, “The hope is... when it shrinks the tumors the pain will go away.”45
“In a 500-patient trial, Rasonque nearly doubled median overall survival to 13.2 months versus 6.7 months for chemotherapy. The approval came 6.5 months ahead of the user-fee deadline, following Breakthrough Therapy and Orphan Drug designations and Priority Review.”
MyChesCo
PR Newswire
