Company Directory

Single-Patient EA Policies/Criteria

At Daiichi Sankyo, we recognize that there are instances when a patient has 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. In these cases, in particular, a treating physician can request the use of an investigational Daiichi Sankyo product prior to regulatory approval for the particular condition or indication, provided it is allowed by the applicable local laws. 

Daiichi Sankyo strives for an equitable balance between the public interest in securing the approval of a new drug and allowing access to certain investigational medicinal products that may have the potential to treat seriously ill patients who cannot be satisfactorily treated with commercially available products.  The following criteria are typically required before Daiichi Sankyo would consider patients eligible for expanded access to a Daiichi Sankyo investigational product. 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 products.
--The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
--The investigational product is under active development (a dose and regimen has been defined and the product 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 indication and the patient population is deemed, to date, to be positive.
--Daiichi Sankyo has decided to seek marketing approval in at least one major market globally.
--The expanded access use of the investigational product will not jeopardize the development of the drug (for instance, granting access to an investigational unapproved drug through expanded 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 product in an expanded access protocol is compliant with local rules and regulations.

Daiichi Sankyo cannot approve expanded access use requests in cases where doing so would violate company policy, local laws or regulations, or if access would present an unacceptable benefit/risk profile, as deemed by medical personnel of the company.  We commit to a careful and fair evaluation of each request by the appropriate medical experts at Daiichi Sankyo within the boundaries of local laws and regulations.

Available Therapies via Single-Patient EA

Daiichi Sankyo does not currently have formal expanded access programs for our other investigational products. We consider granting expanded access to products other than quizartinib on a case-by-case basis, as long as such provision will not delay, interfere with or compromise the completion of clinical trials that are intended to support approval by regulatory authorities, which, in turn, provides access to the medication for the greatest number of individuals.

Disease/Category-Specific EA Policies/Criteria

https://www.daiichisankyo.com/rd/pipeline/index.html

Single-Patient EA Policies/Criteria

• There must be adequate supply of the investigational product to meet the needs of the expanded access program without impacting the company’s clinical trials
• There is a compelling medical and scientific rationale for the requested use
• The potential benefit to the patient must outweigh the collective potential risks
• There must be sufficient clinical data to identify an appropriate dose
• The patient’s physician has determined that treating the patient with the investigational product is in the patient’s best interests

Available Therapies via Single-Patient EA

ExoFlo (extracellular vesicles isolated from human bone marrow mesenchymal stromal/stem cells)

Single-Patient EA Policies/Criteria

At Dizal we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. One of the Dizal's lead products, DZD9008, is an oral EGFR tyrosine kinase inhibitor (TKI). It is currently being investigated as a single agent in a phase 2 clinical trial for the treatment of Non-Small Cell Lung Cancer (NSCLC) patients with EGFR Exon20ins mutation. We are enrolling and conducting clinical trials aiming at gaining regulatory approval to make DZD9008 available to all patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access DZD9008 at this stage of development. Information about our clinical trials, including eligibility criteria and locations, is available at clinicaltrials.gov.

Dizal understands the interest of patients in accessing DZD9008, outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases, however we do not currently offer any Expanded Access programs for DZD9008.

Dizal recognizes the need for Expanded Access programs and will re-evaluate the status of our policy based on data from ongoing and future clinical trials.