Expanded Access

Expanded Access

Expanded access, also known as compassionate use, may be an option for a limited number of individuals with serious or life-threatening conditions, and who have exhausted all available medical options and who do not qualify for clinical trials. Calithera may provide access to its investigational drugs to patients who meet specific criteria through expanded access. Following are some of the general threshold criteria that must be met for Calithera to consider granting expanded access:

• The patient and a licensed physician are both willing to participate.
• The patient’s physician determines that there is no comparable or satisfactory therapy available to diagnose, monitor, or treat the patient’s disease or condition.
• The probable risk to the person from the investigational product is not greater than the probable risk from the disease or condition.
• FDA determines that there is sufficient evidence of the safety and effectiveness of the investigational product to support its use in the particular circumstance;
• The sponsor (generally the company developing the investigational product for commercial use) or the clinical investigator (or the patient’s physician in the case of a single patient expanded access request) submits a clinical protocol (a document that describes the treatment plan for the patient) that is consistent with FDA’s statute and applicable regulations for INDs or investigational device exemption applications (IDEs), describing the use of the investigational product; and
• The patient is unable to obtain the investigational drug under another IND or to participate in a clinical trial.