FDA Approves Breakthrough Oral Drug for Metastatic Pancreatic Cancer, Offering New Hope

The U.S. Food and Drug Administration (FDA) has approved Draksonresib, a novel targeted oral medication for patients with metastatic pancreatic cancer, six and a half months ahead of schedule. This approval marks a significant advancement for a disease with historically poor prognosis, where survival rates have barely improved over recent years. The drug, taken once daily, is expected to become available for import to Israel soon, though its monthly cost may reach tens of thousands of shekels.

Professor Ido Wolf, head of oncology at Tel Aviv's Ichilov Medical Center, explained that metastatic pancreatic cancer patients previously had almost no chance of recovery, with median survival between one and one and a half years under chemotherapy. Draksonresib targets a mutation in the RAS protein, which drives tumor growth in 80 to 90 percent of pancreatic cancers. Unlike past failed attempts to inhibit RAS directly, this drug binds intracellularly to the protein’s active form, blocking signals that promote tumor progression.

In a phase 3 trial involving 500 patients who had prior treatment, Draksonresib nearly doubled median survival to 13.2 months compared to 6.7 months with standard chemotherapy. Professor Wolf described the six-month survival extension as a "real revolution," emphasizing that this first-generation drug opens the door for future therapies. The FDA’s early approval, part of an accelerated pathway for treatments addressing urgent medical needs, underscores the drug’s perceived importance.

While the drug will soon be available in Israel through import, its high cost, estimated at around $30,000 (approximately 90,000 shekels) per month, raises concerns about accessibility. Compassionate use programs providing free access in the U.S. will end following approval. Public health funding in Israel is unlikely before January 2028, as the national drug reimbursement list for 2027 is already closed. This creates a gap during which patients without private insurance or sufficient funds may be unable to afford the treatment.

The FDA approval brings tangible hope to metastatic pancreatic cancer patients, but in Israel, challenges remain regarding who will be able to access the drug and under what financial conditions. The medical community now faces the task of navigating these hurdles to ensure the new therapy benefits those in need.