Following unprecedented results from the RASolute 302 trial, cancer centers across the US are making daraxonrasib available to patients ahead of FDA approval.

The RAS inhibitor has been in the news since it was shown to nearly double median overall survival vs standard chemotherapy — from 6.7 to 13.2 months — among patients with previously treated metastatic pancreatic cancer.

The survival gain, in a notoriously difficult-to-treat disease, earned a standing ovation when the data were presented at this year’s American Society of Clinical Oncology annual meeting. And on July 22, daraxonrasib’s maker Revolution Medicines, announced that the FDA had accepted its approval application.

Many oncologists are already prescribing the drug, however.

At present, more than 2000 patients in the US are being treated with daraxonrasib thanks to an expanded access treatment protocol (EAP), Alan Sandler, MD, Revolution’s chief development officer, told Medscape Medical News.

Under an EAP, patients can gain early access to investigational drugs for serious or life-threatening conditions outside of a clinical trial and before approval when no comparable or satisfactory alternatives exist. The FDA signed off on the daraxonrasib EAP on April 30, just 2 days after receiving a request from Revolution.

According to Sandler, current EAP sites include academic and community cancer centers in almost all 50 states and Puerto Rico, with additional sites coming online.

To participate, physicians contact Revolution through the company website. Revolution then helps the site get approval from its institutional review board (IRB) and site authorization from the FDA. A team at Revolution plus a third-party vendor helps with the process.

Once the EAP is running, Sandler explained, patients are registered on a web portal. If they meet eligibility requirements, daraxonrasib arrives from Revolution in a few days.

The eligibility requirements mirror RASolute’s inclusion criteria, including blood work to ensure appropriate bone marrow, liver, and renal function.

Revolution provides daraxonrasib at no cost, but sites pick up the tab for the IRB review, ongoing safety monitoring, documentation, and other requirements. The paperwork is less than for a clinical trial but can still amount to a few thousand dollars per patient.

“Both sides have to bear some costs,” Sandler said.

“There is definitely an administrative burden and a financial burden to the institution,” said Vaia Florou, MD, medical oncologist at the Huntsman Cancer Institute in Salt Lake City, which launched its EAP in late June with about 15 patients.

In addition to the other expenses, she noted that research coordinators are assigned to patients to gather safety data systematically — much like in a clinical trial but without a trial budget to cover the expense.

Huntsman is swallowing the cost because of the great patient need, Florou said. And because the center is a RASolute study site, she noted, “We know it works. We are excited to offer it to more patients.”

It took the center 2-3 weeks to set up the EAP, and since then getting the drug has been straightforward, according to Florou. The eligibility assessment, she said, is “not too intense. It’s mostly general labs that you assess for any patient who is about to start a cancer treatment.”

The whole process, from patient consent to daraxonrasib delivery, takes about 7-10 days at Huntsman.

The cancer center has already treated about 50 patients in daraxonrasib studies, and Florou has found that patients “definitely prefer” the oral medication over chemotherapy, since it spares them from coming in for infusions and generally has less-severe side effects.

Skin toxicity, including severe rash, is the most pronounced side effect with daraxonrasib. Dose modifications may be necessary, along with topicals and doxycycline, much like how skin toxicity from cetuximab is handled.

“It’s manageable, especially if you involve dermatology early on,” Florou said. 

Meanwhile, Sandler said daraxonrasib development continues. Trials are assessing it in the first line for metastatic pancreatic cancer and after surgery. It’s also being studied in the second line for patients with RAS-mutant non-small cell lung cancer.

Florou reported having no relevant disclosures.

M. Alexander Otto is a physician assistant and award-winning journalist. He is also an MIT science journalism fellow. Email: aotto@medscape.net