Following dynamite data that earned a standing ovation at the American Society of Clinical Oncology meeting in May, Revolution Medicines’ RAS inhibitor daraxonrasib has been approved by the FDA for the treatment of metastatic pancreatic cancer.
The almost guaranteed blockbuster-to-be will now be called Rasonque and offered as a pill for patients with pretreated pancreatic adenocarcinoma, while RevMed races to bring the medicine to earlier lines of therapy while also advancing a pipeline of other RAS inhibitors.
The approval comes more than half a year before the deadline set by the Prescription Drug User Fee Act, Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence, said in an agency press release. The drug was reviewed under the FDA’s Commissioner’s National Priority Voucher program, which was established by former agency leader Marty Makary, M.D.
“This drug showed unprecedented results in an area of high unmet need,” de Claro said.
Acting FDA Commissioner Kyle Diamantas agreed, calling Rasonque “a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer” in the release.
RevMed first started making waves with Rasonque in April, when the RAS inhibitor scored a phase 3 win by doubling overall survival. The biotech followed up by revealing at ASCO that the drug also doubled progression-free survival, along with other detailed analyses, results that led a massive conference audience to rise to their feet in applause.
Speaking with Fierce at the conference, RevMed’s chief development officer, Alan Sandler, M.D., highlighted that patients given Rasonque don’t just live longer—they score better on quality of life metrics, too.
The Ras protein is vital for the survival of many cancers, including the majority of pancreatic cancers, but has long been considered undruggable. RevMed finally nailed down the slippery target by designing daraxonrasib with a unique chemistry so that it glues Ras to another protein, cyclophilin A, which shuts off Ras’ ability to drive cell growth and division.
That same strategy is also used for another of RevMed’s Ras inhibitors, zoldonrasib, which the biotech launched into phase 3 for pancreatic cancer in June. The company also boasts a pipeline of earlier candidates in development for a variety of cancers, and RevMed is cognizant that many competitors want a slice of the Ras pie.
“We're very confident in our approach, and certainly we have a head start over many other companies at this particular time,” Sandler told Fierce at ASCO.