Sponsor Overview
Explore verified public information about Daiichi Sankyo's expanded access programs, compassionate use policies, and patient eligibility pathways. This report aggregates official statements, independent research, and regulatory data to help patients, providers, and sponsors collaborate efficiently.
Unique references curated across 2 content categories.
ClinicalTrials.gov data sources power this status.
Dataset refreshed continuously through Right2Hope ETL pipelines.
Expanded Access Intelligence
Official Statements
Score contribution: 100 — 2 supporting sources.
“Daiichi Sankyo provides an option to give access to investigational products for reasons that include “compassionate use.” This program allows access to investigational products for these patients.”
“In countries and regions where our medicines are not yet approved, we provide certain investigational medicines through Expanded Access Program or similar early access programs to eligible patients with a serious or life-threatening disease or condition, for which all currently available treatment options have been exhausted and enrollment into a clinical trial is not possible.”
Past EAPs on ClinicalTrials.gov
Score contribution: 40 — 3 supporting sources.
Conditions: Epidermal Growth Factor Receptor (EGFR)-Mutated Non Small Cell Lung Cancer
Conditions: Acute Myeloid Leukemia With Gene Mutations
Conditions: EGFRm Advanced Non-Small Cell Lung Cancer, EGFRm Metastatic Non-Small Cell Lung Cancer
Reagan-Udall Foundation Insights
Single-Patient EA Policies/Criteria 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.
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