Sylvester Comprehensive Cancer Center shared on LinkedIn:
“Yesterday’s FDA approval marks a meaningful step forward for patients with metastatic pancreatic cancer.
The FDA has approved daraxonrasib, a first-in-class targeted therapy for adults with metastatic pancreatic adenocarcinoma.
The oral therapy helped patients live nearly twice as long as those who received standard chemotherapy in the phase 3 RASolute 302 trial.
Sylvester participated in the global pivotal trial that led to the approval and was the only site in South Florida to offer the study, providing patients in our region access to the therapy before FDA approval.
Our role in advancing this treatment extends beyond the pivotal trial, and the work continues.
This historic approval represents more than a new treatment. It demonstrates how clinical research can bring new options to patients today while creating opportunities to improve pancreatic cancer treatment for the future.
Learn more here.”
Jashodeep Datta, Assistant Director of Transdisciplinary Research at Sylvester Comprehensive Cancer Center, added on LinkedIn:
“This is a monumental landmark in the treatment landscape of Pancreatic Cancer – and a true beacon of hope for our patients.
The FDA has approved daraxonrasib, a first-in-class oral targeted therapy for metastatic pancreatic cancer.
In the global Phase 3 RASolute 302 trial – we were the only center in South Florida that enrolled patients – those taking the pill lived a median of 13.2 months, nearly twice as long as those on standard chemotherapy.
Even more remarkable, the FDA approved it for eligible patients regardless of KRAS mutation status – a breadth of benefit that is unprecedented in this disease.
Yet it is also a call to action that this is not the finish line, but a new starting point.
Response to daraxonrasib is finite, and resistance is expected to be near universal.
Here at Sylvester Comprehensive Cancer Center, we are at the forefront of thinking about the next generation of combinations to tackle and dismantle resistance.
The future of pancreatic cancer treatment will be built on understanding why tumors respond, how resistance develops, the contributions from tumor cells and their microenvironment, and what combinations can make responses deeper and more durable.
That’s the work we’re committed to – today, tomorrow, and beyond.”
You can also read: FDA Approves Daraxonrasib: First-in-Class RAS Inhibitor for Metastatic Pancrea