The Food and Drug Administration on Wednesday approved a groundbreaking new drug for advanced pancreatic cancer, offering U.S. patients a more effective treatment against one of the deadliest types of cancer, according to Kiro7. FDA officials granted expedited approval to the first-of-a-kind pill, called daraxonrasib, which blocks a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases. The daily pills will be sold by Revolution Medicines under the brand name Rasonque.
FDA Approves Rasonque for Advanced Pancreatic Cancer
The company announced that a one-month supply of the medication would cost approximately $39,800. In a randomized, open-label, multicenter clinical trial involving 500 adults with previously treated metastatic pancreatic adenocarcinoma whose cancer had stopped responding to prior treatment, patients taking the drug nearly doubled their survival time with fewer severe side effects compared to chemotherapy recipients. Patients receiving the new treatment lived for a median of 13.2 months, compared with 6.7 months for those who received standard chemotherapy, as detailed by WCJB. Side effects reported in the study included skin rash, mouth sores, diarrhea, and other digestive issues.
Targeting the Once-Undruggable KRAS Mutations
Pancreatic cancer has historically been difficult to tackle compared to other cancers that have benefited from a variety of chemotherapy alternatives. The new drug targets mutations in the RAS gene family that normally regulate cell growth, specifically KRAS mutations that are critical in fueling pancreatic cancer. According to Theridgefieldpress, a structure that previously made it hard for drugs to stick to mutated proteins meant this cancer driver was long considered undruggable, an approach that had eluded drugmakers for decades. Revolution Medicines’ drug uses a molecular glue to bind with multiple KRAS subtypes.
Acting FDA Commissioner Dr. Kyle Diamantas noted in a statement that regulators approved the drug more than six months ahead of their target date, completing an urgent review. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,
Diamantas said.
Public Attention and High-Profile Patient Experience
Pancreatic cancer remains among the most deadly forms of cancer largely because it is difficult to detect before it spreads to other organs. The American Cancer Society estimates approximately 67,000 new cases will be diagnosed in the United States, with more than 52,000 people dying from the disease, and a five-year overall survival rate of 13%.
Medical Community Outlook and Future Research
Medical professionals welcomed the regulatory decision, viewing it as a major step forward for oncology. This is one of the most anticipated approvals I can think of,
said Dr. Andrew Coveler of the Fred Hutch Cancer Center, adding, This medicine is not a cure but a significant improvement.
Dr. Pashtoon Kasi of City of Hope Orange County noted that while the medication is not a cure, it’s the best option we’ve ever had.
Kasi and other doctors treating pancreatic cancer hope the approval will pave the way for additional options across other forms of cancer, with scores of experimental treatments currently in development. Revolution Medicines, based in Redwood City, California, is already studying its technology for several other forms of cancer, including lung cancer.
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