NHO Revive to open expanded access for Daraxonrasib

NHO Revive plans to begin an Expanded Access Protocol next week for eligible stage 4 pancreatic cancer patients who may qualify for Daraxonrasib before FDA approval. The program will accept referrals from physicians and patient inquiries while the investigational therapy remains under regulatory review.

Why it matters: - The Expanded Access Protocol could give some stage 4 pancreatic cancer patients another treatment option when standard care is no longer working or cannot be tolerated. - The program offers pre-approval access to an investigational therapy while Daraxonrasib continues through the FDA review process.

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

The details: - Expanded access, also called compassionate use, is designed for patients with serious or life-threatening conditions who do not qualify for an ongoing clinical trial. - Eligibility is limited to patients with stage 4 pancreatic cancer who cannot tolerate current treatment or whose disease has progressed on their current line of treatment, as determined by a treating physician. - 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 NHO Revive website.

Between the lines: - The program signals a bridge between clinical development and real-world patient access for a hard-to-treat cancer. - The announcement also highlights how expanded access can be used when trial enrollment is not possible but physicians believe a patient may benefit from an investigational drug.

What's next: - NHO Revive expects to activate the protocol next week. - Physicians and patients can begin seeking eligibility review once the program opens. - Daraxonrasib will remain available through the protocol until FDA approval or an end to the program.

The bottom line: - NHO Revive is creating a pathway for select pancreatic cancer patients to try Daraxonrasib before it is approved in the U.S.