NHO Revive to open pre-approval access to Daraxonrasib for stage 4 pancreatic cancer patients

NHO Revive plans to launch an Expanded Access Protocol next week that could let eligible stage 4 pancreatic cancer patients receive Daraxonrasib before potential FDA approval. The program is meant for patients who cannot tolerate current treatment or whose disease has progressed, and referrals are expected to open once the protocol goes live.

Why it matters: - The Expanded Access Protocol could give some patients with stage 4 pancreatic cancer access to an investigational therapy before U.S. Food and Drug Administration approval. - The program is aimed at patients who have limited treatment options because their disease has progressed or they cannot tolerate their current regimen. - Expanded access can matter when a patient does not qualify for a clinical trial but still needs another option.

What happened: - NHO Revive said it will activate an Expanded Access Protocol for Daraxonrasib next week. - The protocol is intended to provide pre-approval access for eligible patients with stage 4 pancreatic cancer. - Once active, NHO Revive will accept referrals from healthcare providers and inquiries from patients who want to know whether they qualify. - Access will continue until Daraxonrasib receives FDA approval or the protocol is discontinued.

The details: - The protocol is limited to eligible patients whose treating physician determines they are unable to tolerate their current treatment or whose disease has progressed on their current line of treatment. - Daraxonrasib remains an investigational therapy and has not been approved by the FDA. - Expanded Access, also called compassionate use, allows some patients with serious or life-threatening conditions to receive an investigational treatment when they do not qualify for an ongoing clinical trial and meet specific criteria. - Patients and physicians interested in the program are being directed to contact NHO Revive. - More information is available on the NHO Revive website. - NHO Revive is a joint initiative between Nebraska Hematology Oncology and Revive Research Institute. - Nebraska Hematology-Oncology has served Lincoln and surrounding communities since 1997. - Nebraska Hematology-Oncology says it has seven physicians, 13 advanced practice providers and more than 145 staff. - Nebraska Hematology-Oncology says it was the first QOPI-certified and Oncology Medical Home APC4-certified clinic in Nebraska. - Additional information about Nebraska Hematology-Oncology is available at YourCancerCare.com.

Between the lines: - The launch signals growing use of expanded access programs as a bridge for patients facing serious illness while regulatory review continues. - The structure also suggests NHO Revive wants to move quickly once the protocol becomes active, with referrals and patient questions handled immediately.

What's next: - NHO Revive expects the Expanded Access Protocol to begin next week. - Physicians and patients who believe they may qualify can contact NHO Revive for screening once the protocol opens. - The program will remain available until FDA approval or until NHO Revive ends the protocol.