FDA approves Revolution Medicines’ pancreatic cancer treatment Rasonque

The US Food and Drug Administration (FDA) approved Revolution Medicines’ RAS inhibitor daraxonrasib as a treatment for metastatic pancreatic cancer.

The FDA said on the 27th (local time) that it had authorized the marketing of the oral treatment Rasonque for patients with pancreatic adenocarcinoma who had previously received treatment.

Angelo De Claro, director of the FDA’s Oncology Center of Excellence, described it as “a drug that has shown unprecedented results in an area with a significant unmet medical need.” Kyle Diamantas, acting FDA commissioner, also called Rasonque “an important new option for patients facing a very difficult and historically hard-to-treat cancer.”

The approval came more than six months ahead of the review deadline set by the FDA. The drug was reviewed through the National Priority Voucher program introduced by former FDA Commissioner Marty Makary.

Revolution Medicines began attracting attention in April after Rasonque produced results in a phase 3 clinical trial showing that it doubled overall survival. In May, the company presented a detailed analysis at the American Society of Clinical Oncology (ASCO) showing that the drug also doubled progression-free survival, receiving a standing ovation from the large audience.

At the time, Revolution Medicines Chief Development Officer (CDO) Alan Sandler emphasized that patients not only lived longer but also scored better on quality-of-life measures.

The Ras protein plays a critical role in the survival of many cancers, including most pancreatic cancers, but has long been considered difficult to target with drugs. In designing daraxonrasib, Revolution Medicines used a unique chemical structure that causes Ras to bind to another protein, cyclophilin A, thereby blocking Ras’s function of promoting cell growth and division.

The same strategy was applied to the company’s other Ras inhibitor, zoldonrasib. Revolution Medicines advanced zoldonrasib into a phase 3 clinical trial for pancreatic cancer in June.

At ASCO, CDO Sandler said, “We are very confident in our approach and are clearly ahead of many other companies at this point.”