FDA Approves Breakthrough Drug for Advanced Pancreatic Cancer Extending Survival

The U.S. Food and Drug Administration (FDA) has approved a groundbreaking drug called Daraxonrasib (brand name Rasonque) for patients with advanced metastatic pancreatic cancer. This approval marks a historic breakthrough in treating one of the deadliest cancers, which has seen little progress for decades. The FDA expedited the review process, completing it over six months ahead of schedule due to the drug's significant potential.

Daraxonrasib targets the RAS protein, a key driver in over 90% of pancreatic cancer cases, which had long been considered an "undruggable" target. Clinical trials involving 500 patients who had previously undergone treatment showed that those receiving Daraxonrasib had a median survival of 13.2 months, nearly double the 6.7 months for patients on standard chemotherapy. The treatment also resulted in higher response rates and improved quality of life.

Leading cancer centers in the U.S. hailed the approval as a paradigm shift, anticipating it will pave the way for new therapies targeting RAS mutations in other cancers. However, the drug's high cost presents a major challenge. Revolution Medicines, the manufacturer, set the monthly price at $39,800 (approximately 135,000 shekels). While assistance programs will be available in the U.S., the expense may limit access globally.

In Israel, oncologists and patients are expected to show strong interest. The drug can be imported through existing channels following its U.S. launch, but inclusion in the national health basket may take many months or longer. This delay could leave many patients facing a life-extending treatment they cannot afford.