NHO Revive to open expanded access for Daraxonrasib in stage 4 pancreatic cancer

NHO Revive plans to start an Expanded Access Protocol next week to let eligible stage 4 pancreatic cancer patients receive Daraxonrasib before possible FDA approval. The program is aimed at patients whose disease has progressed or who cannot tolerate current treatment.

Why it matters: - The Expanded Access Protocol could give eligible stage 4 pancreatic cancer patients access to an investigational therapy when standard options are no longer working. - The program opens a pathway for patients who may not qualify for a clinical trial but still meet physician-reviewed eligibility criteria. - Access remains limited because Daraxonrasib is not yet FDA-approved.

What happened: - NHO Revive said it expects to activate an Expanded Access Protocol for Daraxonrasib next week. - The program will allow pre-approval access for eligible patients with stage 4 pancreatic cancer. - NHO Revive will begin accepting referrals from healthcare providers and inquiries from patients once the protocol is active.

The details: - Expanded access, also called compassionate use, is designed for patients with serious or life-threatening conditions who may not qualify for an ongoing clinical trial. - The protocol is intended for stage 4 pancreatic cancer patients whose disease has progressed on their current treatment or who cannot tolerate their current treatment, as determined by their treating physician. - Access will continue until Daraxonrasib receives FDA approval or the protocol is discontinued. - Daraxonrasib remains an investigational therapy and has not been approved by the FDA. - Patients and physicians seeking more information can contact NHO Revive. - More information is available on the company's website.

Between the lines: - The move signals growing use of expanded access as a bridge for patients facing advanced disease before regulatory clearance arrives. - The physician evaluation requirement means access will be individualized, not automatic. - Dr. Kailash Mosalpura, a medical oncologist at Nebraska Hematology-Oncology, said the program reflects a commitment to giving eligible patients additional treatment opportunities while regulatory review continues.

What's next: - NHO Revive will start taking referrals and patient questions after the protocol goes live. - Eligibility decisions will depend on physician assessment and protocol requirements. - The program will end if FDA approval comes through or if NHO Revive discontinues the protocol. - NHO Revive said it will provide more information as the Expanded Access Protocol launches.