BUFFALO, N.Y. (WKBW) — A groundbreaking new drug for advanced pancreatic cancer has been approved by the Food and Drug Administration, and doctors at Roswell Park Comprehensive Cancer Center in Buffalo played a key role in the clinical trial that helped pave the way for the treatment.
FDA officials on Wednesday granted expedited approval to daraxonrasib, a first-of-its-kind pill that targets a mutated protein that fuels tumor growth in more than 90% of pancreatic cancer cases.
Roswell Park was one of the sites involved in the clinical trial, giving Western New York patients access to the experimental treatment during its development.
Dr. Christos Fountzilas, who led the effort at Roswell Park, called the FDA approval a major moment.
“It's definitely a huge milestone,” Dr. Fountzilas said.
He said Roswell Park's participation in the drug's development is particularly meaningful because it allowed patients in Western New York to take part in research that could ultimately change the standard of care for pancreatic cancer.
“We're blessed being able to participate in the development of this drug and offer it to patients in Western New York,” Fountzilas said.
WATCH: Groundbreaking pancreatic cancer drug approved by FDA; Roswell Park played key role in trial
The daily pill will be sold by Revolution Medicines under the brand name Rasonque. The company says a one-month supply will cost approximately $39,800.
The approval comes after a company-funded study involving 500 patients with metastatic pancreatic cancer whose disease had stopped responding to previous treatment. Patients were randomly assigned to receive either daraxonrasib or additional chemotherapy.
Patients who received the new drug lived a median of 13.2 months, compared with 6.7 months for those receiving chemotherapy — nearly doubling survival time. The drug also produced fewer severe side effects than chemotherapy, although patients experienced problems including skin rash, mouth sores, diarrhea and other digestive issues.
“This is one of the most anticipated approvals I can think of,” Dr. Andrew Coveler of the Fred Hutch Cancer Center told the Associated Press. “This medicine is not a cure but a significant improvement.”
Pancreatic cancer remains one of the deadliest forms of cancer, in large part because it is difficult to detect before it spreads to other organs.
The American Cancer Society estimates about 67,000 people will be diagnosed with pancreatic cancer in the United States this year, while more than 52,000 will die from the disease. The five-year overall survival rate is just 13%.
Earlier this year, former Sen. Ben Sasse, a Republican from Nebrasks, told "60 Minutes" on CBS that he experienced less pain taking the medication compared to standard chemotherapy.
FDA regulators said they approved the drug more than six months ahead of their target date.
“It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” FDA acting commissioner Kyle Diamantas said in a statement.
The Associated Press contributed to this report
