US approves a revolutionary pill for pancreatic cancer: “It’s a huge breakthrough” Choose us as your preferred source on Google. The US Food and Drug Administration (FDA) has approved Rasonque, developed by Revolution Medicines, which nearly doubles survival in cases of metastatic pancreatic cancer after…
US approves a revolutionary pill for pancreatic cancer: “It’s a huge breakthrough”
Choose us as your preferred source on Google.
The US Food and Drug Administration (FDA) has approved Rasonque, from Revolution Medicines, which nearly doubles survival in patients with metastatic pancreatic cancer after demonstrating…
Revolution Medicines (RevMed) has received regulatory approval in the United States for its pancreatic cancer drug, the first medicine targeting one of the disease’s main molecular drivers. The drug, called daraxonrasib and marketed under the name Rasonque, represents one of the most significant advances in pancreatic cancer treatment in years.
In a late-stage trial published in May, daraxonrasib nearly doubled the usual survival time for patients with an aggressive form of the disease, to 13.2 months, compared with 6.7 months for those who received chemotherapy, the current standard treatment, according to the US Food and Drug Administration (FDA).
The drug has been approved for patients with metastatic disease who have already received at least one systemic treatment or who are not candidates for this type of therapy. Side effects include skin rashes and mouth sores, according to the FDA. RevMed did not immediately respond to a request for comment on the cost of the treatment.
“This approval offers a critical new option today to patients facing an extraordinarily difficult cancer that has historically been very challenging to treat. It is our fundamental duty to provide patients with more cures and treatments that improve their lives as quickly as possible,” acting FDA Commissioner Kyle Diamantas said Wednesday.
The drug is one of the first medicines capable of broadly and effectively targeting RAS, a protein associated with tumor growth that is mutated in most cases of pancreatic cancer. For years, researchers struggled to develop drugs that could work against all its forms, until RevMed developed an innovative approach based on a “molecular tail” that essentially neutralizes the dangerous protein.
“It’s a huge breakthrough,” said Eileen O’Reilly, an oncologist at Memorial Sloan Kettering Cancer Center and one of the lead authors of the late-stage trial, in an interview before the decision was announced.
A single daily pill
Because it is taken as a single daily pill, daraxonrasib could allow patients with incurable diseases to spend more time at home with their families rather than at an infusion center receiving treatment. The company is also conducting clinical trials to expand its use to earlier stages of the disease.
Pancreatic cancer has a high mortality rate: only about 13% of patients survive five years. According to the American Cancer Society, more than 67,000 cases of pancreatic cancer will be diagnosed this year, and more than 52,000 people will die from the disease.
The enthusiasm surrounding RevMed’s cancer drug has sent the company’s shares sharply higher over the past year.
According to data compiled by Bloomberg, Wall Street analysts expect the drug to generate more than $9 billion in sales by 2032. The drug gained significant attention in April when former US Senator Ben Sasse announced that he was taking it after being diagnosed with stage 4 pancreatic cancer.
Demand from patients and their families was intense ahead of the approval. In May, the FDA authorized RevMed to open a special expanded-access program allowing patients who did not qualify for ongoing clinical trials to obtain the drug. By early August, the company reported that it had provided the drug to more than 2,000 patients through the program.
The drug also received an expedited review as part of a new FDA voucher program designed to speed up the approval of promising medicines. In a statement, the FDA said it reviewed the drug 6.5 months ahead of the regulatory deadline.
