Expanded Access Policy
Ikena Oncology is committed to developing therapies with the potential to target underlying mechanisms driving cancer survival and growth, aiming to address unmet medical needs of cancer patients. As part of our mission, we are committed to conducting well designed clinical trials in an ethical manner to determine if our new investigational drugs are safe and effective and obtain necessary regulatory approvals that could allow patients access to our products. Ikena’s open clinical trials are listed on www.clinicaltrials.gov and can be found here.
In some cases, patients with serious or life-threating diseases or conditions may not be eligible for clinical trials and may not have other treatment options. In such cases, a new investigational drug may be provided prior to regulatory approval or commercial availability, under a provision referred to as “expanded access” (also commonly called “compassionate use”) by the U.S. Food and Drug Administration (“FDA”). Under specific circumstances, we will consider making one of our new investigational drugs available for individual patients to treat a life-threatening or serious disease or condition outside of a clinical trial, when no other alternative treatment options exist.
Ikena evaluates expanded access requests on a case-by-case basis. The request for expanded access for individual patients must be submitted directly to Ikena Oncology at EAP@ikenaoncology.com by a licensed physician from a qualified treatment center in the U.S., who will monitor and supervise the treatment of the patient. Please do not include a patient’s personally identifiable information when submitting any request for expanded access.
All the following criteria must be met for an expanded access request to be considered:
- The patient must have a life-threatening or serious condition or disease for which no other treatment options exist
- The patient is not an eligible candidate for any available clinical trial
- There must be an open Investigational New Drug application (IND) in the US, under which human clinical trials are conducted in this country
- There must be sufficient scientific evidence of the requested new investigational drug, considering all available safety and efficacy information, that the potential benefit likely outweighs the potential risks. This typically occurs only after Phase I studies are completed
- The patient meets any other important medical criteria established by the medical experts working on the new investigational drug development program
- There must be an adequate supply of the new investigational drug without interfering with any ongoing and planned clinical trials
- The requested use does not compromise the program development, including clinical trials or regulatory pathways
- All treating physicians who request a new investigational drug through expanded access must comply with all applicable laws and regulations, including those related to safety reporting
- Once the U.S. Food and Drug Administration has approved a new investigational drug for any indication, any expanded access program will be discontinued as the drug is no longer investigational
We will aim to acknowledge receipt of a submitted request within five (5) business days. Each request will be reviewed by a team at Ikena Oncology in accordance with our policy; meeting these criteria does not secure expanded access to our investigational products.
Additional questions about our expanded access policy can be inquired by contacting EAP@ikenaoncology.com.
This policy may be revised at any time in accordance with the 21st Century Cures Act.
Last updated on July 1st, 2022.