FDA approves drug that doubles survival for advanced pancreatic cancer

The US Food and Drug Administration (FDA) has approved daraxonrasib for patients with metastatic pancreatic cancer, following a clinical trial that showed it doubled median survival compared to chemotherapy alone.

The drug targets a genetic mutation known as KRAS, which is linked to about 90% of pancreatic cancer cases, according to the Daily Mail.

Approval was granted for patients whose cancer has spread to other organs after undergoing chemotherapy, with the treatment taken as two pills daily.

Results from a clinical trial involving around 500 patients showed those who received daraxonrasib had a median survival of 13.2 months, compared to 6.7 months for those on standard chemotherapy—an average increase of about six months, with some patients living for years after starting treatment.

The group treated with the drug experienced milder side effects than those on chemotherapy, mainly rash, diarrhea, fatigue, and nausea.

Daraxonrasib works by disabling the KRAS protein, which limits the growth and spread of cancer cells.

Dr. Brian Wolpin, who led the clinical trial at the Dana-Farber Cancer Institute in Boston, said the drug offers doctors new options to improve both survival and quality of life for patients.

Pancreatic cancer challenges and drug launch

Pancreatic cancer remains a major challenge due to the difficulty of early detection, as symptoms often appear vaguely—such as back pain, indigestion, fatigue, and yellowing of the eyes or skin—leading to diagnosis after the cancer has spread beyond the pancreas.

According to the American Cancer Society, the five-year survival rate after diagnosis is just 12%, with around 67,000 new cases and about 52,000 deaths annually in the United States.

Revolution Medicines will market the drug under the brand name Rasonque. More than 2,000 patients have already received the drug free of charge since May through an expanded access program, and patients will later be transitioned to their private insurance providers.

While daraxonrasib is not a cure, it offers a new treatment option for patients with metastatic pancreatic cancer, addressing a critical gap in available therapies.