Every year, World Cancer Research Day is a chance to pause and ask a simple question: what does research actually change for the person sitting in the exam room? At Baptist Health Cancer Care, part of Baptist Health South Florida, one answer just became official. The FDA has approved daraxonrasib (brand name Rasonque), a first-of-its-kind oral targeted therapy for adults with metastatic pancreatic adenocarcinoma — and Baptist Health physicians helped generate the evidence behind it, alongside parallel advances in how radiation is used to treat the disease.

A Disease That Has Been Hard to Move

Pancreatic adenocarcinoma, the most common form of pancreatic cancer, accounts for roughly 90 to 95 percent of cases. It's notoriously difficult to catch early, because symptoms often don't appear until the disease has already spread. Metastatic disease — cancer that has moved beyond the pancreas — has historically been treated with intravenous chemotherapy, which can help some patients but comes with significant side effects and, for many, limited long-term success. The five-year survival rate for pancreatic cancer has long lagged behind most other cancers, and progress has tended to be incremental rather than transformative.

That is the backdrop against which this approval lands.

Kyaw Aung, M.B.B.S., Ph.D., a medical oncologist specializing in gastrointestinal cancers at Baptist Health Herbert Wertheim Cancer Institute, doesn't understate what it means. "This is fantastic news for all pancreatic cancer patients," Dr. Aung said. "This approval marks a new era for pancreatic cancer treatment."

Targeting the Switch That Won't Turn Off

For years, scientists considered the KRAS protein essentially "undruggable." KRAS acts like an on-off switch inside cells, helping regulate normal growth and division. In many cancers — pancreatic cancer chief among them — a mutation locks that switch in the "on" position, allowing cancer cells to multiply without restraint. Its complex structure made it stubbornly resistant to drug development, even as researchers understood exactly how central it was to the disease.

Daraxonrasib changes that. Rather than broadly attacking fast-growing cells the way chemotherapy does, it's designed to target activated RAS proteins directly, cutting off the growth signal at its molecular source.

"Daraxonrasib is a targeted treatment, not chemotherapy," Dr. Aung explained. "It works differently from chemotherapy by targeting activated KRAS protein in pancreatic cancer cells." That distinction — attacking a specific molecular driver rather than cells broadly — is what separates this generation of therapy from the standard of care that's defined pancreatic cancer treatment for decades.

What the Trial Data Show

The FDA's approval was based on the RASolute 302 Phase 3 clinical trial, which enrolled 500 adults with previously treated metastatic pancreatic adenocarcinoma. Participants received either daily oral daraxonrasib or standard intravenous chemotherapy, allowing researchers to compare outcomes head-to-head.

The results were striking:

• Median overall survival: 13.2 months with daraxonrasib versus 6.7 months with chemotherapy
• Risk of death: approximately 60 percent lower among patients on daraxonrasib
• Progression-free survival: nearly double that of chemotherapy

Median overall survival marks the point at which half of trial participants are still alive; progression-free survival tracks how long patients live before their cancer starts growing again. Improvements of this size in either measure are considered highly meaningful in oncology research, and here, patients saw meaningful movement in both.

Sarbajit Mukherjee, M.D., chief of Gastrointestinal Medical Oncology at Baptist Health Miami Cancer Institute, has been closely involved in evaluating the therapy and put it plainly: "In the study, patients on daraxonrasib lived almost twice as long, which is something we have never seen before in this setting for pancreatic cancer." He's careful to note that the drug isn't a cure and that cancer cells can eventually develop resistance to the blockade, but his overall assessment is unambiguous: "This is the first true 'step-change' drug we've seen for advanced pancreatic cancer in many years. It gives patients more time, often with better quality of life, and opens the door to much smarter, more personalized treatment in the future." Even before daraxonrasib was commercially available, Baptist Health Cancer Care treated more than 20 patients with the therapy through an expanded access program, giving those patients an early opportunity to benefit from the drug. Baptist Health Cancer Care is also offering next generation KRAS drugs through phase 3 clinical trials and innovative antibody drug conjugates through early phase clinical trials for our patients with advanced pancreatic cancer.

Understanding the Side Effects

Like all cancer treatments, daraxonrasib carries risks. The most commonly reported side effects in clinical trials included rash, diarrhea, stomatitis (mouth soreness and inflammation), nausea, fatigue, vomiting, abdominal pain, swelling, decreased appetite and bleeding, with rash reported most frequently. Dr. Mukherjee notes that in the trials so far, most of these problems have been manageable with dose adjustments and supportive medications — but patients and their care teams still need to monitor closely and report new symptoms promptly. Eligibility for treatment depends on a patient's diagnosis, treatment history and tumor characteristics, and is determined individually with an oncology team.

Could This Mean Less Reliance on Chemotherapy?

Perhaps the most striking part of this approval is what it signals about where treatment is headed. Chemotherapy has anchored pancreatic cancer care for decades. A successful, precisely targeted alternative raises a question that wouldn't have seemed realistic even a few years ago.

"We can now envisage a future with no chemotherapy needed for pancreatic cancer patients," Dr. Aung said. "This is a remarkable milestone." Chemotherapy remains an important option today, but the field is increasingly focused on treatments matched to a tumor's specific genetic and molecular profile — and the success of daraxonrasib may accelerate that shift.

That shift may not stop at pancreatic cancer. KRAS mutations aren't unique to this disease; similar genetic changes drive a number of other cancers, including lung and colorectal cancer. "KRAS mutations are found in multiple other cancers, including lung cancer and colorectal cancers, and this approval also opens up opportunities for KRAS-targeted treatments for those with other cancers," Dr. Aung said. "We will see significant advances in the near future in KRAS-targeted therapy for other cancer types."

Baptist Health's Role on the National Stage

This is not research that happened somewhere else and was simply reported on at Baptist Health — it's research Baptist Health physicians helped drive. Dr. Aung was named a co-author on a landmark study published in The New England Journal of Medicine detailing earlier-phase results of daraxonrasib across RAS-mutated cancers, placing Baptist Health Cancer Care alongside investigators from many of the nation's leading cancer centers on one of oncology's most closely watched drug programs.

That contribution reflects something larger about Baptist Health Cancer Care's research trajectory: clinical trial enrollment across the system has more than doubled over the past five years, part of a broader portfolio spanning brain cancer, lung cancer, breast cancer and beyond. Pancreatic cancer research at Baptist Health also extends past drug therapy alone — the institution is among the early U.S. adopters credentialed to use tumor-treating fields, a wearable device, for pancreatic cancer following the Phase 3 PANOVA-3 trial. Michael Chuong, M.D., vice chair and medical director of radiation oncology at Baptist Health Cancer Care, is the principal investigator for a new trial combining the SMART radiation approach with tumor-treating fields for patients with locally advanced pancreatic cancer.

Radiation Therapy Is Entering a New Era, Too

Drug therapy isn't the only front where the standard of care is shifting. In August 2026, the American Society for Radiation Oncology (ASTRO) released an updated clinical practice guideline that substantially expands and modernizes how radiation is used in pancreatic cancer — replacing guidance that had stood since 2019. Dr. Chuong, who is also a professor and vice chair of the Department of Oncological Sciences at Florida International University's Herbert Wertheim College of Medicine, co-chaired the multidisciplinary task force that wrote it.

The central shift is dose escalation. Historically, radiation doses for pancreatic tumors were limited because the pancreas sits close to radiosensitive organs — mainly the stomach and intestines — that shift position with breathing and daily anatomical changes. Newer technology, including magnetic resonance-guided linear accelerators, lets clinicians see the tumor and surrounding organs in real time and adjust the treatment plan each day, making it possible to safely deliver much higher, ablative doses of radiation.

"These advances allow us to safely deliver substantially higher radiation doses that can improve clinical outcomes including local tumor control and potentially overall survival for select patients," Dr. Chuong said. "We can also treat more comprehensively than was possible when the previous guideline was published."

That recommendation is backed by data Baptist Health helped generate. Herbert Wertheim Cancer Institute was one of the highest-enrolling centers in the international, multi-institutional Phase 2 SMART trial, which tested a five-fraction, MR-guided adaptive radiation approach in patients with borderline resectable or locally advanced pancreatic cancer, and Dr. Chuong served as a co-principal investigator. Long-term results from 136 patients showed a two-year overall survival of 53.6 percent from diagnosis — substantially higher than what's typically seen with standard-dose radiation. "The ability to deliver ablative doses of radiation increases the probability of long-term tumor control, and may also improve overall survival for some patients," Dr. Chuong said, noting that this matters most for patients whose tumors can't be removed surgically.

A related Baptist Health study, looking at patterns of disease recurrence among 121 patients treated with ablative radiation, found that expanding the treatment area to cover not just the visible tumor but also nearby high-risk tissue — including specific neural pathways and lymph node regions — was associated with fewer local and regional failures. Among patients whose treatment covered that full at-risk area, none experienced a local or regional recurrence, a finding that is now informing the updated ASTRO guideline's broader treatment-target recommendations.

A New Chapter for Patients and Families

For patients facing a metastatic pancreatic cancer diagnosis, advances have often felt incremental. This approval, paired with the parallel progress being made in radiation therapy, is something different: a validated, FDA-approved targeted strategy that nearly doubled median survival in a large randomized trial, arriving alongside real gains in how radiation can be delivered more precisely and at higher doses.

As Baptist Health Cancer Care's Chief Scientific Officer, Dr. Manmeet Ahluwalia expressed excitement at the two developments in the field and stated "It is rare for challenging cancer like Pancreatic cancer to move on two fronts within the same year. A targeted therapy that nearly doubles survival, arriving alongside a rewritten national radiation guideline, tells us pancreatic cancer is no longer the field where progress stalls and our physicians helped generate the evidence behind both."  Dr. Aung's own words capture where that leaves patients today: "This is fantastic news for all pancreatic cancer patients. This approval marks a new era for pancreatic cancer treatment."

On World Cancer Research Day, that's the measure Baptist Health Cancer Care is working toward — one trial, one publication and one patient at a time.

To learn more about clinical research at Baptist Health Cancer Care, visit BaptistHealth.net/CancerCare.