5 Years of Pancreatic Cancer Advances: A Timeline of FDA Approvals and What They Mean for Patients

November is Pancreatic Cancer Awareness Month. For years, pancreatic cancer was known as a disease where progress came slowly. That's starting to change. Over the past five years, the FDA has approved new chemotherapy regimens, targeted drugs for tumors with specific genetic changes, a wearable device and, in August 2026, the first drug designed to block the RAS proteins that drive most pancreatic cancers.

People living with the disease have felt that shift. "With new treatments appearing each month, what may have been a long shot yesterday is now within reach," longtime pancreatic cancer survivor William Ramshaw wrote in a 2025 CURE blog about living to see his daughters' weddings.

Below is a timeline of the key approvals, in the order they happened. Each entry gives the approval date so you can tell older milestones from recent ones, followed by what it means for patients today.

A Few Terms That Will Help

Most of these approvals are based on how long people in a clinical trial lived, or how long their cancer stayed in check. Median survival is the midpoint: half the people in a group lived longer than that number, and half lived less. Progression-free survival is how long people went before their cancer grew or spread.

Some drugs received accelerated approval. This lets the FDA approve a treatment based on early results, such as how many people's tumors shrank, while larger studies confirm the benefit. Many of the newer drugs also depend on tumor testing (sometimes called biomarker or molecular testing), which looks for genetic changes in the cancer itself. That's different from germline testing, a blood or saliva test for gene changes you were born with and could share with family members.

2022: Drugs That Follow the Gene Change, Not the Organ

Some approvals during this period weren't specific to pancreatic cancer. Instead, they cover any solid tumor, including pancreatic cancer, that carries a particular genetic change. These changes are rare in pancreatic cancer, but for people who have them, the drugs can be an important option.

On June 22, 2022, the FDA granted accelerated approval to Tafinlar (dabrafenib) plus Mekinist (trametinib) for solid tumors with a BRAF V600E mutation that have grown after earlier treatment and have no satisfactory alternatives. Three months later, on Sept. 21, 2022, the FDA approved Retevmo (selpercatinib) for solid tumors with a RET gene fusion that have grown on or after earlier treatment or have no satisfactory alternatives. A gene fusion happens when two genes break and join together, creating an abnormal signal that can fuel cancer growth.

What it means today: These approvals are one reason doctors recommend genetic testing of the tumor for everyone with advanced pancreatic cancer. The only way to know whether a drug like these is an option for you is to have your tumor tested.

February 2024: A New Chemotherapy Option for a First Treatment

On Feb. 13, 2024, the FDA approved Onivyde (irinotecan liposome) with oxaliplatin, fluorouracil and leucovorin, a combination known as NALIRIFOX, as a first treatment for metastatic pancreatic adenocarcinoma. Adenocarcinoma is the most common type of pancreatic cancer, and metastatic means it has spread to other parts of the body.

The approval was based on the phase 3 NAPOLI 3 trial of 770 people who had not yet been treated for metastatic disease. People who received NALIRIFOX lived a median of 11.1 months, compared with 9.2 months for those who received gemcitabine plus nab-paclitaxel, a long-standing standard. They also went longer before their cancer grew, a median of 7.4 months vs 5.6 months. Common side effects included diarrhea, fatigue, nausea, vomiting and decreased appetite. CURE covered the approval at the time.

What it means today: NALIRIFOX is one of several first-line chemotherapy options. Which regimen is best depends on your overall health and how well you can tolerate side effects, so it's worth talking through the trade-offs with your oncologist before treatment starts.

April and June 2024: Two More Approvals Based on Tumor Markers

Two more approvals for any solid tumor with a specific marker followed in 2024. On April 5, 2024, the FDA granted accelerated approval to Enhertu (fam-trastuzumab deruxtecan-nxki) for solid tumors that are strongly HER2-positive after earlier treatment, when no satisfactory alternatives exist. HER2 is a protein found on the surface of some cancer cells, and "strongly positive" means a lab test called IHC gave the tumor the highest score, 3+. On June 13, 2024, the FDA approved Augtyro (repotrectinib) for solid tumors with an NTRK gene fusion.

What it means today: Like the 2022 approvals, these apply to a small group of people with pancreatic cancer. Broad tumor testing, which checks many genes at once, gives you the fullest picture of which options might fit you.

December 2024: A Targeted Drug for NRG1 Fusions

On Dec. 4, 2024, the FDA granted accelerated approval to Bizengri (zenocutuzumab-zbco) for advanced pancreatic adenocarcinoma with an NRG1 gene fusion that has grown during or after earlier treatment. It was also approved for non-small cell lung cancer with the same fusion.

In the eNRGy study, tumors shrank in 40% of the 30 people with NRG1 fusion-positive pancreatic cancer, and those responses lasted from 3.7 to 16.6 months. Bizengri carries a boxed warning, the FDA's most serious type of warning, because it can harm an unborn baby. CURE reported on the approval in December 2024.

What it means today: NRG1 fusions are rare, so many people won't qualify, but this approval is another reason comprehensive tumor testing matters. Because it was an accelerated approval, continued approval may depend on results from further studies.

March 2025: An Option for Pancreatic Neuroendocrine Tumors

On March 26, 2025, the FDA approved Cabometyx (cabozantinib) for previously treated, well-differentiated pancreatic neuroendocrine tumors (pNETs), as well as neuroendocrine tumors outside the pancreas, in adults and children 12 and older.

pNETs are a less common, usually slower-growing type of pancreatic cancer that starts in the pancreas's hormone-making cells and is treated differently from pancreatic adenocarcinoma. "Well-differentiated" means the cancer cells still look fairly similar to normal cells under a microscope, which usually signals slower growth. In the phase 3 CABINET trial, people with pNETs who took Cabometyx went a median of 13.8 months before their cancer grew, compared with 3.3 months for those who took a placebo, an inactive pill. Common side effects included fatigue, high blood pressure, diarrhea and mouth sores, and most patients needed a dose break or reduction.

What it means today: Knowing exactly which type of pancreatic cancer you have shapes every treatment decision. CURE contributor Miranda L. Anderson-Cromer wrote about waiting weeks after surgery for lab testing to confirm where her rare neuroendocrine cancer began, because treatment "was completely dependent on where the cancer originated from." For more on how these tumors differ, read CURE's overview of pNETs.

February 2026: A Wearable Device for Locally Advanced Disease

On Feb. 12, 2026, the FDA approved Optune Pax for adults with locally advanced pancreatic cancer, meaning cancer that has grown into nearby blood vessels or tissue, so it usually can't be removed with surgery, but hasn't spread to distant organs. The device delivers Tumor Treating Fields, electric fields that disrupt cancer cells as they try to divide, through patches worn on the abdomen. The FDA described it as a first-of-its-kind device for the disease.

In the PANOVA-3 trial of 571 people, those who used Optune Pax with gemcitabine and nab-paclitaxel lived a median of 16.2 months, compared with 14.2 months with chemotherapy alone. They also went longer before their pain got worse, 15.2 months vs 9.1 months. Skin irritation where the patches are placed was the most common device-related side effect. Read CURE's coverage of the approval.

What it means today: The device must be worn for many hours a day, so it's worth talking with your care team about how it would fit into your routine, from work to sleep to time with family.

August 2026: The First Broad RAS-Targeted Drug

On Aug. 26, 2026, the FDA approved Rasonque (daraxonrasib), a once-daily pill, for adults with metastatic pancreatic adenocarcinoma who have received at least one earlier systemic therapy (treatment that travels through the whole body, such as chemotherapy), or who are not candidates for multidrug chemotherapy. RAS genes are altered in about 90% of pancreatic cancers. These genes work like an on switch for cell growth, and when they're altered, the switch can get stuck in the on position. For decades, they were considered impossible to target with a drug.

In the phase 3 RASolute 302 trial, people who took Rasonque lived a median of 13.2 months, compared with 6.7 months with chemotherapy, a 60% lower risk of death. Median progression-free survival was 7.2 months vs 3.6 months. The most common side effects included rash, diarrhea, mouth sores, nausea and vomiting.

"For patients, that means there is more hope and another treatment option after standard chemotherapy," Dr. Kristin Higgins of City of Hope Atlanta told CURE in an interview about the approval. Also, for more on the trial behind it, read CURE's conversation with Dr. Paul Oberstein.

What it means today: Rasonque is approved after earlier treatment, not as a first treatment. Studies are testing whether it helps when used earlier. Planning ahead for that next step is something patients CURE has spoken with stress. Dan, who was diagnosed with stage 4 pancreatic cancer just before turning 41 and is now in complete remission and off treatment, told CURE he started asking about clinical trials while chemotherapy was still working. "Patients need to advocate for themselves," he said. "They need to ask questions as early as possible: 'Is this working? What's next?'"

What Five Years of Progress Adds Up To

Five years ago, most people with advanced pancreatic cancer had a short list of chemotherapy options. Today, treatment increasingly depends on what's driving the tumor, from RAS and NRG1 to HER2 and NTRK. That makes genetic testing of the tumor, and inherited (germline) testing, more important than ever.

Sharon, a 14-year pancreatic cancer survivor, told CURE she already knew she carried an inherited BRCA mutation but never connected it to pancreatic cancer until her diagnosis. That mutation ended up guiding the personalized treatment she received. Dr. Jonathan Lee, who answered common pancreatic cancer questions in a Cancer Search Bar episode, called this one of the most exciting times in pancreatic cancer research in decades, as drugs aimed at targets once considered "undruggable" move forward.

Survival with pancreatic cancer is still too short, and these drugs add months, not cures, for most people. But patients like the 20-year survivor CURE profiled are a reminder of why researchers keep pushing. As Ramshaw put it, "No matter how dire your situation may seem, there is always hope, no matter how faint."

References

1. U.S. Food and Drug Administration. "FDA Grants Accelerated Approval to Dabrafenib in Combination With Trametinib for Unresectable or Metastatic Solid Tumors With BRAF V600E Mutation." June 22, 2022.
2. U.S. Food and Drug Administration. "FDA Approves Selpercatinib for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors." Sept. 21, 2022.
3. U.S. Food and Drug Administration. "FDA Approves Irinotecan Liposome for First-Line Treatment of Metastatic Pancreatic Adenocarcinoma." Feb. 13, 2024.
4. U.S. Food and Drug Administration. "FDA Grants Accelerated Approval to Fam-Trastuzumab Deruxtecan-nxki for Unresectable or Metastatic HER2-Positive Solid Tumors." April 5, 2024.
5. U.S. Food and Drug Administration. "FDA Approves Repotrectinib for Adult and Pediatric Patients With NTRK Gene Fusion-Positive Solid Tumors." June 13, 2024.
6. U.S. Food and Drug Administration. "FDA Grants Accelerated Approval to Zenocutuzumab-zbco for Non-Small Cell Lung Cancer and Pancreatic Adenocarcinoma." Dec. 4, 2024.
7. U.S. Food and Drug Administration. "FDA Approves Cabozantinib for Adults and Pediatric Patients 12 Years of Age and Older With pNET and epNET." March 26, 2025.
8. U.S. Food and Drug Administration. "FDA Approves First-of-Its-Kind Device to Treat Pancreatic Cancer." Feb. 12, 2026.
9. Revolution Medicines. "U.S. FDA Approves Revolution Medicines' RASONQUE (daraxonrasib), the First Broad RAS-Targeted Medicine in Metastatic Pancreatic Cancer." Aug. 26, 2026.

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