FDA Approves Israeli-Developed Drug Nearly Doubling Survival in Advanced Pancreatic Cancer

The U.S. Food and Drug Administration (FDA) has approved Rasonque (daraxonrasib), a new targeted oral medication for metastatic pancreatic adenocarcinoma, marking a significant breakthrough in a cancer type with historically limited treatment options. The approval, announced yesterday, applies to adults with metastatic pancreatic cancer who have received at least one prior systemic therapy or are unsuitable for multi-drug systemic treatment. Daraxonrasib inhibits the RAS protein family, a key driver in pancreatic cancer development, and is taken once daily as a tablet.

This approval is based on the international Phase 3 RASolute 302 trial involving 500 patients whose disease progressed after prior treatment. The study showed that median overall survival nearly doubled to 13.2 months with daraxonrasib compared to 6.7 months with chemotherapy. Progression-free survival also improved significantly, with 7.2 months versus 3.6 months, and the objective tumor response rate was 31.6% versus 11.2%. These results were presented at the American Society of Clinical Oncology (ASCO) annual meeting and published in the New England Journal of Medicine.

Israeli oncologist Prof. Ido Wolf of Ichilov Medical Center expressed surprise at the early FDA approval, months ahead of schedule, and noted the potential for relatively rapid introduction of the drug in Israel. However, he cautioned that the compassionate use program will close, meaning the drug will only be available for payment. Currently, daraxonrasib is not registered in Israel, and access will depend on import pathways, regulatory approvals, availability, and cost.

The drug targets the RAS pathway, mutated in over 90% of pancreatic cancers, particularly the KRAS gene. For decades, RAS was considered an almost untreatable target due to its protein structure, but daraxonrasib acts as a pan-RAS active inhibitor, effective against multiple RAS forms. While the drug can cause side effects such as rash, diarrhea, mucositis, nausea, fatigue, and abdominal pain, severe adverse events were somewhat less frequent than with chemotherapy, and treatment discontinuation due to side effects was low.

Pancreatic cancer remains one of the deadliest cancers, with about 67,000 new U.S. cases annually, mostly adenocarcinomas diagnosed at advanced stages. Although daraxonrasib is not a cure and individual patient benefit varies, extending median survival from under seven months to over a year represents a major advance. The next challenge is making the drug accessible to patients in Israel, including determining the timing, regulatory route, and pricing.