By Rajwa Quasim
The Food and Drug Administration (FDA) gave expedited approval this week to a first-of-its-kind pill for advanced pancreatic cancer, one of the deadliest forms of cancer. FDA regulators said Wednesday that the drug was approved more than six months ahead of schedule.
The approved drug, daraxonrasib, will be sold under the brand name Rasonque by Revolution Medicines. The drug targets a mutated protein responsible for driving tumor growth in more than 90% of pancreatic cancer cases. The approval marks a major development after decades of efforts to target a protein long considered difficult to treat. The drug targets mutated forms of the RAS protein, including KRAS, which fuels pancreatic cancer.
The company said the drug would cost around $39,800 for a one-month supply. The approval was based largely on results from a clinical trial involving 500 patients whose metastatic pancreatic cancer had stopped responding to previous treatment.
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Patients were randomly assigned to receive either the new drug or additional chemotherapy. Those who received daraxonrasib lived for a median of 13.2 months, compared with 6.7 months for patients who underwent chemotherapy. Patients receiving the new drug also reported fewer side effects, with common symptoms including skin rash, mouth sores and digestive issues.
Dr. Andrew Coveler of the Fred Hutch Cancer Center said, “This is one of the most anticipated approvals I can think of. This medicine is not a cure but a significant improvement.”
The results have been described by cancer specialists as a significant advance because pancreatic cancer has historically had limited treatment options. The five-year survival rate for pancreatic cancer remains about 13%, highlighting the need for more effective therapies. The American Cancer Society projects roughly 67,000 new diagnoses in the U.S. this year and more than 52,000 deaths.
The FDA’s acting commissioner, Kyle Diamantas, said, “It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”
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Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center, suggested that the breakthrough will likely spur more trials applying similar molecular strategies. He said, “I think this has opened doors for many other companies. Downstream, I think there are going to be a lot more trials looking at this approach in other tumor types.”
Daraxonrasib gained public attention when former Sen. Ben Sasse, who represented Nebraska, said he experienced less pain while taking it under an expanded access program the FDA had allowed ahead of formal approval.
In a press release, the FDA said, “This action demonstrates the agency’s commitment to moving with urgency, reducing unnecessary delays and advancing innovative treatments that can make a meaningful difference in the lives of American patients and their families. […] The approval is for the treatment of adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.”