The Food and Drug Administration approved Rasonque, a $39,800 once-daily pill developed by Revolution Medicines, on Wednesday. The drug targets multiple forms of the RAS protein, which drives tumor growth in most pancreatic cancers and about a quarter of all human cancers. It is approved for adults with metastatic pancreatic adenocarcinoma who have tried one round of treatment or cannot receive combination chemotherapy, without requiring a test for a specific RAS mutation, according to fortune.com.
Rasonque’s approval followed clinical trials led by Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute. Wolpin said the drug’s success offers physicians confidence that directly inhibiting RAS can significantly benefit patients. Anna Berkenblit of the Pancreatic Cancer Action Network described the approval as the most significant advance in pancreatic cancer treatment to date, per fortune.com.
The approval is notable because RAS mutations were long considered undruggable, making this a breakthrough in oncology. Pancreatic adenocarcinoma accounts for 90% to 95% of pancreatic cancer cases and is one of the hardest cancers to treat. The drug’s mechanism could pave the way for therapies targeting other cancers driven by RAS mutations, which affect roughly 25% of all human cancers, fortune.com reports.
Rasonque will be available to patients with metastatic pancreatic adenocarcinoma who have exhausted other options or cannot tolerate combination chemotherapy. The drug’s approval marks a milestone in cancer treatment, with pricing set at $39,800 per treatment course, as detailed by fortune.com.