FDA gives expedited approval to new groundbreaking pancreatic cancer drug

On Wednesday, the U.S. Food and Drug Administration granted approval to a revolutionary new drug for pancreatic cancer, the most common form of this lethal disease. The first-of-its-kind pill, named daraxonib, was granted expedited approval by FDA officials. This drug targets a mutated protein that drives tumor growth in over 90% of pancreatic cancer cases.

The pill, manufactured by Revolution Medicines and sold under the brand name Rasonque, emerged from a study where patients taking it nearly doubled their survival time, with fewer severe side effects, compared to those receiving chemotherapy. The study, conducted and funded by the company, enrolled 500 patients whose metastatic, or spreading, cancer had stopped responding to previous treatments.

Patients on the new treatment lived a median of 13.2 months, compared to 6.7 months for those on chemotherapy. Dr Pashtoon Kasi, a cancer specialist in California, noted that while the drug is not a cure, it represents the best option available for these patients. Pancreatic cancer is notoriously difficult to detect early due to its asymptomatic nature, leading to a low five-year overall survival rate of 13%.

Earlier this year, former Senator Ben Sasse discussed on CBS's "60 Minutes" how the drug reduced his pain. This approval came more than six months ahead of schedule, with FDA officials emphasizing their duty to deliver life-saving treatments to patients swiftly. The drug's success marks a breakthrough, as pancreatic cancer has long been considered "undruggable" due to structural challenges in targeting its mutated proteins.

Doctors hope this drug could pave the way for more treatments targeting other cancers, as several experimental drugs are currently in development.