Revolution Medicines Inc. secured U.S. Food and Drug Administration approval for Rasonque, a once-daily pill for metastatic pancreatic cancer, at an annual list price exceeding $475,000.
The clinical evidence is stark: patients on Rasonque survived a median 13 months versus 6.7 months on standard chemotherapy in a late-stage trial published in May. This near-doubling of survival time in an aggressive cancer type with only a 13 percent five-year survival rate represents a material shift in treatment outcomes.
The drug targets RAS, a protein mutated in most pancreatic cancers and historically resistant to pharmaceutical inhibition. Revolution Medicines deployed a "molecular glue" mechanism that inactivates RAS directly—a scientific approach researchers spent decades attempting to develop.
Rasonque is indicated for patients with metastatic disease who have completed chemotherapy or are ineligible for multidrug regimens. Reported side effects include rash and mouth sores. The oral formulation allows home administration, reducing treatment center visits for patients with incurable disease.
Pancreatic cancer kills roughly 52,000 Americans annually from approximately 67,000 diagnoses, according to the American Cancer Society. Most cases are diagnosed after metastasis.
Brian Wolpin, director of the Hale Family Center for Pancreatic Cancer Research at Dana-Farber Cancer Institute, said the approval "represents an advance that has been long awaited and long deserved."
Memorial Sloan Kettering oncologist Eileen O'Reilly, a lead author of the trial, called Rasonque "a huge advance."
Revolution Medicines' stock rose 1.9 percent Wednesday following approval. The shares have more than doubled since April, giving the company a market capitalization exceeding $46 billion. Wall Street analysts project the drug will generate over $9 billion in annual sales.
AbbVie Inc. and Merck Co. explored potential acquisition deals with Revolution Medicines earlier this year, though those discussions later ceased.
Revolution Medicines is running additional trials to evaluate Rasonque in earlier-stage pancreatic cancer and in lung cancer applications.
