The following criteria are typically required before Daiichi Sankyo would consider patients eligible for early Medical Access to a Daiichi Sankyo investigational medicine. All criteria are subject to local laws and regulations.

The patient suffers from a life-threatening or serious disease or condition where there is an unmet medical need that cannot be met by existing therapeutic options.
The patient is ineligible or unable to participate in any ongoing clinical study of the investigational medicine.
The investigational medicine is under active development (a dose and regimen has been defined and the investigational medicine is typically in Phase 2 development or beyond) and has not been placed on regulatory or any other hold.
The benefit-risk profile of the drug in the potential indication and the patient population is deemed, to date, to be positive. This typically occurs when Daiichi Sankyo has decided to seek marketing approval in at least one major market globally.
Daiichi Sankyo has the intent to seek marketing approval in at least one major market globally.
The use of the investigational medicine through the Medical Access program will not jeopardize the development of the investigational medicine (for instance, granting access to an investigational medicine through medical access should not delay, interfere with, or compromise the completion of clinical trials that are intended to support approval by regulatory authorities).
The use of the investigational medicine in a protocol for the Medical Access program is compliant with local rules and regulations.
Daiichi Sankyo cannot approve a request for an investigational medicine through a Medical Access program in cases when doing so would violate company policy, local laws or regulations, or if access may present an unacceptable benefit/risk profile, as determined by medical personnel of the company.