FDA Approves New Pill for Advanced Pancreatic Cancer

The Food and Drug Administration on Wednesday approved daraxonrasib, a first-of-its-kind pill for advanced pancreatic cancer, granting it expedited approval more than six months ahead of schedule.

The drug will be sold by Revolution Medicines under the brand name Rasonque, at a cost of about $39,800 for a one-month supply, the company said.

Daraxonrasib blocks a mutated protein called RAS that fuels tumor growth in more than 90% of pancreatic cancer cases — a target scientists have called "undruggable" for roughly 40 years, according to Dr. Céline Gounder, CBS News medical correspondent.

In a company-funded study of 500 patients with metastatic pancreatic cancer whose disease had stopped responding to prior treatment, those given daraxonrasib lived a median of 13.2 months, compared with 6.7 months for those who received additional chemotherapy. Patients on the new drug also reported fewer severe side effects, though skin rash, mouth sores and diarrhea were among the reported issues.

"This is one of the most anticipated approvals I can think of," said Dr. Andrew Coveler of the Fred Hutch Cancer Center. "This medicine is not a cure but a significant improvement."

Pancreatic cancer is among the deadliest cancers because it is often detected only after it has spread. The American Cancer Society estimates about 67,000 new cases will be diagnosed in the U.S. this year, with more than 52,000 deaths; the five-year survival rate is 13%.

Former Sen. Ben Sasse of Nebraska, diagnosed with stage-four pancreatic cancer in December, told "60 Minutes" in April that daraxonrasib had been highly effective for him, citing a 76% reduction in tumor volume over four months. He said doctors had initially given him a three- to four-month life expectancy.

FDA acting commissioner Kyle Diamantas said in a statement, "It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible."

Doctors say the approval could open the door to similar treatments for other cancers driven by RAS mutations, including lung cancer, which Revolution Medicines is also studying.