RevMed receives early FDA approval for ‘groundbreaking’ pancreatic cancer drug

 

The FDA granted the approval of Revolution Medicines’ daraxonrasib, now to be known as Rasonque, in pancreatic adenocarcinoma 6.5 months ahead of deadline.

Revolution Medicines, which stunned the oncology world with data showing a doubling of survival in pancreatic cancer with its RAS inhibitor daraxonrasib earlier this year, has been granted an early FDA approval for the asset.

Daraxonrasib will now be known as Rasonque after the FDA gave its stamp of approval on Wednesday morning.

The greenlight arrived months ahead of schedule, capping off a whirlwind journey for the company that emerged in the public consciousness when Phase 3 data showed potentially practice-changing results for the oral RAS(ON) multi-selective, non-covalent inhibitor.

Daraxonrasib achieved overall survival of 13.2 months compared to 6.7 months for chemotherapy in the Phase 3 RASolute 302 trial. This result was enough for RevMed to take the therapy to the FDA for an early approval, which the agency was keen to give in a disease that has just a 13% survival rate five years after diagnosis. The FDA granted multiple designations for swifter regulatory review, including the Commissioner’s National Priority Voucher.

“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer. It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible,” Acting FDA Commissioner Kyle Diamantas said in a statement. “I am immensely proud of the dedicated FDA scientists whose fast, thorough review and relentless commitment made this groundbreaking milestone a reality.”

Rasonque can now be used to treat adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy.

But the FDA had already cleared early access to patients with the disease back in May. The agency said Wednesday that 90–95% of pancreatic cancer cases diagnosed in the U.S. each year are pancreatic adenocarcinoma. These patients face a bleak prognosis, as the disease is typically detected late and moves aggressively.

“This drug showed unprecedented results in an area of high unmet need,” Angelo de Claro, director of the FDA’s Oncology Center of Excellence, said in a statement. “The approval was granted 6.5 months before the user fee deadline, demonstrating the FDA’s commitment to accelerating the approval of new cancer treatments for patients with serious and life-threatening conditions.”

https://www.biospace.com/drug-development/revmed-receives-early-fda-approval-for-groundbreaking-pancreatic-cancer-drug