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FDA approves landmark pancreatic cancer drug that's shown to improve survival
Confirmed
Former US Senator Ben Sasse, who announced in December he had been diagnosed with Stage 4 pancreatic cancer, is in a clinical trial for the drug and has said it has helped shrink his tumours. "Most patients get the diagnosis of pancreatic cancer quite late, at which point its already metastatic, it's already spread," said Dr. Céline Gounder, CBS News medical correspondent.
The FDA said the drug provided a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer". "I think this has opened doors for many other companies," said Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center.
"This is one of the most anticipated approvals I can think of," said Dr. Andrew Coveler of the Fred Hutch Cancer Center. FDA regulators noted on Wednesday that they approved the drug more than six months ahead of their target date.
Sasse said the drug had been extremely effective for him, describing it as a "miracle drug. The agency then approved the drug six months ahead of the regulatory deadline because it "showed unprecedented results in an area of high unmet need", said Angelo de Claro, director of the the agency's Oncology Center of Excellence.
It’s the biggest development we’ve had in pancreas cancer in decades,” said Andrew Ko, a medical oncologist specializing in gastrointestinal cancers at the University of California, San Francisco. A late-stage clinical trial with 500 patients found those who took the daily pill had an average survival time of 13.2 months, compared to 6.6 months for those on chemotherapy.
In 2025, the FDA granted the drug a "Breakthrough Therapy" designation, given to treatments for serious conditions that warrant an expedited review. "It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible," the FDA's acting commissioner, Kyle Diamantas, said in a statement.
Sasse said that when he was diagnosed in December, doctors had given him a "three- to four-month life expectancy. The most common side effects of the treatment were rash, diarrhoea, nausea, fatigue and vomiting, the FDA said.
What's confirmed
- "This is one of the most anticipated approvals I can think of," said Dr. Andrew Coveler of the Fred Hutch Cancer Center.
- FDA regulators noted on Wednesday that 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," the FDA's acting commissioner, Kyle Diamantas, said in a statement.
- "I think this has opened doors for many other companies," said Dr. Pashtoon Kasi of City of Hope Orange County, a California-based cancer center.
- Sasse said the drug had been extremely effective for him, describing it as a "miracle drug.
- Former US Senator Ben Sasse, who announced in December he had been diagnosed with Stage 4 pancreatic cancer, is in a clinical trial for the drug and has said it has helped shrink his tumours.
What's still developing
- "Most patients get the diagnosis of pancreatic cancer quite late, at which point its already metastatic, it's already spread," said Dr. Céline Gounder, CBS News medical correspondent.
- Sasse said that when he was diagnosed in December, doctors had given him a "three- to four-month life expectancy.
- A late-stage clinical trial with 500 patients found those who took the daily pill had an average survival time of 13.2 months, compared to 6.6 months for those on chemotherapy.
- The FDA said the drug provided a "critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer".
- In 2025, the FDA granted the drug a "Breakthrough Therapy" designation, given to treatments for serious conditions that warrant an expedited review.
- The agency then approved the drug six months ahead of the regulatory deadline because it "showed unprecedented results in an area of high unmet need", said Angelo de Claro, director of the the agency's Oncology…
- The most common side effects of the treatment were rash, diarrhoea, nausea, fatigue and vomiting, the FDA said.
- It’s the biggest development we’ve had in pancreas cancer in decades,” said Andrew Ko, a medical oncologist specializing in gastrointestinal cancers at the University of California, San Francisco.