The Food and Drug Administration on Wednesday approved a groundbreaking pancreatic cancer drug that experts predict will transform treatment for the notoriously deadly disease.
The drug, Revolution Medicines’ Rasonque, or daraxonrasib, was approved for patients with advanced pancreatic cancer who have already tried a prior treatment, such as chemotherapy, the agency said.
In a late-stage clinical trial of 500 patients, people who got the drug along with standard chemotherapy lived about twice as long — 13.2 months, on average — compared with people who received chemotherapy alone.
Seven of those patients were treated in Chicago through City of Hope Cancer Center.
The drug was provided through a compassionate use program approved in May, according to the facility.
“Each of these patients was logged into a website through the FDA. All of them got drug,” said Dr. Ajaz Khan, a physician scientist at City of Hope.
“We were planning to enroll a total of 50 [patients] over the next three months, and suddenly, today, we wake up this morning, and it’s approved by the FDA,” said Khan who called it “incredible news.”
Rasonque is taken as a daily pill. It targets a mutation in a gene called KRAS that’s found in nearly all pancreatic cancers as well as many lung, colorectal, ovarian and other cancers. The gene acts like an on/off switch controlling how cells grow in the body. The mutation causes it to get stuck in the “on” position, spurring cells to grow out of control.
Scientists have known for years that if they could target the mutation, they could force the switch from its “on” position. But efforts have failed until Rasonque.
The drug was available in Chicago at three institutions based upon an expanded access program (EAP) after the first initial clinical trial results were published and presented at a national conference in Chicago on June 1.
“I can tell you in 20 years I’ve been going there, this was probably the third time there was a standing ovation for 10 minutes straight. That’s how incredible the news was when we got the information about the drug,” said Khan.
Northwestern Medicine is also part of the EAP and said its first patient started treatment with daraxonrasib last week.
Other patients are scheduled to start soon, and according to the hospital, there is currently no limit on how many patients could get it.
Dr. Deva Mahalingam, a professor of medicine at Northwestern specializing in pancreatic cancer, says his team was eagerly awaiting the approval.
“Over the years, with a lot of work across the country, and also with this company, Revolution Medicine, they were able to target the protein KRAS by binding to that protein like a glue, and preventing this protein, that typically will require partner proteins to work with it to try and allow signals to be sent down into a cancer cell for it to grow.”
“By binding to this protein, they prevent that signaling pathway, therefore preventing tumor cells from growing,” said Mahalingam.
He calls it a “fundamental change” in how we think about pancreatic cancer using targeted therapy.
The drugmaker did not say how much Rasonque would cost or how quickly it would be available.
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