FDA approves Revolution Medicines’ pancreatic cancer drug Daraxonrasib, doubling survival

The U.S. Food and Drug Administration (FDA) has approved Revolution Medicines’ pancreatic cancer treatment daraxonrasib. Sold under the brand name Rasonqu, the drug is an oral pill for patients with metastatic pancreatic cancer.

The FDA said on the 27th (local time) that it had approved Rasonqu for patients with pancreatic adenocarcinoma who had received prior treatment. Angelo De Claro, director of the FDA’s Oncology Center, described it as “a drug that has shown unprecedented results in an area of high unmet need.”

The approval came more than 6 months ahead of the review deadline set by the FDA. The review was conducted through the National Priority Review Voucher program introduced by former FDA Commissioner Marty Makary.

Revolution Medicines announced in April that Rasonqu had doubled overall survival in a phase 3 clinical trial. The company then presented a detailed analysis at the American Society of Clinical Oncology (ASCO) meeting in June showing that progression-free survival had also doubled, drawing a standing ovation from the large audience.

“Patients not only lived longer, but also scored better on quality-of-life measures,” said Alan Sandler, chief development officer (CDO), at the time.

Ras proteins are essential for the survival of several cancers, including most pancreatic cancers, but have long been considered difficult drug targets. Revolution Medicines designed daraxonrasib with a unique chemical structure that binds Ras to another protein, cyclophilin A, to block cell growth and division.

The same strategy was applied to another Ras inhibitor, zoldonrasib. The company advanced zoldonrasib into a phase 3 clinical trial for pancreatic cancer in June. “We are confident in our approach and are ahead of many other companies at this point,” Sandler, the CDO, said.