Revolution Medicines Secures USFDA Early Access Nod for Pancreatic Cancer Drug Daraxonrasib
Bengaluru: The U.S. Food and Drug Administration has authorized the granting of early access before regulatory approval to Revolution Medicines' pill for patients with previously treated pancreatic cancer, the company said on Friday.
The regulator's early access program allows patients with serious or life-threatening conditions to receive experimental treatments outside clinical trials before approval.
The drug, daraxonrasib, is being studied in patients with metastatic pancreatic ductal adenocarcinoma (PDAC), a form of pancreatic cancer that has spread to other parts of the body, who have already been treated with other therapies.
Revolution said in April that daraxonrasib doubled the survival period in pancreatic cancer patients compared with chemotherapy in a closely watched late-stage trial, sending the company's shares sharply higher.
The pill is also being evaluated in other late-stage trials, including for non-small cell lung cancer.
Daraxonrasib has also received an FDA priority review voucher, which is intended to speed the development and review of drugs that address unmet medical needs.
Revolution Medicines said it was working to open the early access program as quickly as possible in the U.S., while ensuring access is safe and equitable.
Under FDA rules, patients and caregivers cannot apply directly to the company for access. Requests must be made by a licensed treating physician, Revolution Medicines said.
