Nuvation Bio understands that there are some cases when a patient is unable to participate in a clinical trial and other treatment options have been exhausted. In those cases, the patient’s physician may choose to request access to an investigational drug outside of a clinical trial through an Expanded Access pathway.  Expanded Access refers to a pathway in which patients with serious or immediately life-threatening diseases may gain access to an investigational drug outside the context of participation in clinical trials designed to evaluate safety and efficacy.

At this time, Nuvation Bio products are considered investigational, which means that they have not been approved as safe and effective by regulatory health authorities, such as the United States Food and Drug Administration (FDA). 

Currently for NUV-868 and NUV-1511, participation in clinical trials is the only way for patients to gain access to these investigational drugs. As more clinical data on the safety and efficacy of these investigational drugs become available, Nuvation Bio will review and update its policy on Expanded Access.  For information on Nuvation Bio’s clinical trials, please email clinicaltrials@nuvationbio.com.

For information on the Expanded Access policy for taletrectinib and safusidenib, visit the AnHeart Therapeutics website.