NHO Revive to open expanded access for Daraxonrasib

NHO Revive plans to launch an expanded access protocol next week that could let eligible stage 4 pancreatic cancer patients receive Daraxonrasib before possible FDA approval. The program will accept referrals from physicians and inquiries from patients once active, with access limited to patients who meet eligibility criteria.

Why it matters: - The expanded access protocol could give some stage 4 pancreatic cancer patients a treatment option when current therapy is no longer working or cannot be tolerated. - The program creates a pathway to receive Daraxonrasib before U.S. Food and Drug Administration approval, if patients meet the protocol requirements. - Expanded access is designed for serious or life-threatening conditions when patients do not qualify for an ongoing clinical trial.

What happened: - NHO Revive said it expects to activate an Expanded Access Protocol for Daraxonrasib next week. - The protocol is intended for eligible stage 4 pancreatic cancer patients. - NHO Revive will accept referrals from healthcare providers and inquiries from patients once the program is active. - Access will continue until Daraxonrasib receives FDA approval or the protocol is discontinued.

The details: - The protocol is for patients whose disease has progressed on their current treatment or who cannot tolerate their current line of therapy, as determined by the treating physician. - Daraxonrasib remains an investigational therapy and has not been approved by the FDA. - Patients and physicians interested in the program are encouraged to contact NHO Revive. - 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 its team includes seven physicians, 13 advanced practice providers and more than 145 staff. - The clinic says it is Nebraska's first QOPI-certified and Oncology Medical Home APC4-certified clinic. - More information is available at the company’s announcement. - Nebraska Hematology Oncology directs readers to YourCancerCare.com for more information. - NHO Revive also listed its social media pages on LinkedIn, Instagram and Facebook.

Between the lines: - The move signals an effort to broaden access to an investigational cancer therapy while the regulatory review process continues. - Expanded access programs can matter most for patients who have exhausted standard treatment options and need a physician-guided alternative. - The protocol also positions NHO Revive as an access point for referrals, not just a research partner.

What's next: - NHO Revive expects the Expanded Access Protocol to begin next week. - Physicians and patients can seek eligibility screening once the program opens. - The access pathway will remain in place until FDA approval or discontinuation of the protocol.

The bottom line: - NHO Revive is preparing to open a pre-approval access route for Daraxonrasib that could reach a limited group of advanced pancreatic cancer patients.