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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

Diakonos Oncology Inc. is a biotechnology company dedicated to the development of immunotherapies to treat late-stage cancers through a novel approach to Dendritic Cell Vaccines. DOC1021 is a multi-step process that harnesses the patient’s natural immune response, utilizing the manner in which the body mounts an anti-viral response to target and eliminate cancer cells.

Currently, access to our Dendritic Cell Vaccine can be obtained through enrollment in one of our clinical studies for Glioblastoma Multiforme (NCT04552886) and Pancreatic Adenocarcinoma (NCT04157127). The objective of these clinical studies is to evaluate patient safety and efficacy

For expanded access use to our investigational products, we encourage patients to contact us at expandedaccess@diakonosoncology.com for an evaluation.

Diakonos Oncology will assess each request on a case-by-case scenario; however, we cannot guarantee that investigational products will be made available. In any requests for expanded access use, please consider the following the US Food and Drug Administration guidelines for Expanded Access Programs.

Available Therapies via Single-Patient EA

Dendritic Cell Vaccine for the treatment of individuals diagnosed with Glioblastoma Multiforme and Pancreatic Adenocarcinoma.

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

Sunvozertinib (DZD9008)
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, sunvozertinib, is an oral EGFR tyrosine kinase inhibitor (TKI). It is currently being investigated as a single agent in phase 2 and phase 3 clinical trials 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 sunvozertinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access sunvozertinib 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 drugs, such as sunvozertinib, outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. Because sunvozertinib is an investigational drug, and its efficacy and safety are still under evaluation, sunvozertinib can only be administrated in accordance with local investigational drug requirement by an experienced physician.
Dizal now offers Individual Patient Access for its investigational drug sunvozertinib for the treatment of adult patients with Advanced Non-Small Cell Lung Cancer (NSCLC), with EGFR or HER2 mutation, at the sites participating in ongoing clinical trials of sunvozertinib. Individual patients at these sites may be able to access sunvozertinib if they are ineligible for the available standard of care and are recommended by the treating physician to the Individual Patient Access Program.
In order to meet FDA requirements, Dizal will provide a Letter of Authorization (LOA), referencing the content in Dizal’s US IND, to each treating physician to support their written requests (IND) for individual patient use. This same principle may be applied to countries with IND/CTA of sunvozertinib opened to fulfill the local regulatory requirements.

Golidocitinib (DZD4205, AZD4205)
At Dizal, we aspire to discover and develop differentiated therapeutics for the treatment of cancer and immunological diseases. One of Dizal's lead products, golidocitinib, is an oral, potent, highly selective Janus kinase 1 (JAK1) inhibitor. It is currently being investigated as a single agent in a phase 2 clinical trial for the treatment of patients with relapsed/refractory peripheral T-cell lymphoma (r/r PTCL). We are conducting clinical trials aiming at gaining regulatory approval to make golidocitinib available to all eligible patients as quickly as possible. As such, we believe participation in our clinical trials is the most appropriate way to access golidocitinib 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 drugs, such as golidocitinib, outside of clinical trials and prior to regulatory approval for potentially life-threatening diseases. Because golidocitinib is an investigational drug, and its efficacy and safety are still under evaluation, golidocitinib can only be administered in accordance with local investigational drug requirements by an experienced physician.
Dizal now offers Individual Patient Access to the investigational drug golidocitinib for the treatment of adult patients with r/r PTCL at the sites participating in ongoing clinical trials of golidocitinib. Individual patients at these sites may be able to access golidocitinib if they are ineligible for the available standard of care and are recommended by the treating physician to the Individual Patient Access Program.
In order to meet the FDA's requirements, Dizal will provide a Letter of Authorization (LOA), referencing the content in Dizal's US IND, to each treating physician to support their written requests (IND) for individual patient use. The same principle may be applied to countries with IND/CTA of golidocitinib opened to fulfill the local regulatory requirements.

 

Available Therapies via Single-Patient EA

DZD9008 (INN name: sunvozertinib): Non-Small Cell Lung Cancer (NSCLC) patients with EGFR Exon20ins mutation
DZD4205 (AZD4205, INN name: golidocitinib): Relapsed/refractory peripheral T-cell lymphoma (r/r PTCL)
 

Available Therapies via Single-Patient EA

Dren Bio does not currently offer expanded access to our investigational products. Dren Bio believes that the most appropriate access to our investigational products is through participation in any of our ongoing clinical trials because this offers the best means to ensure the safe product usage and to generate the necessary data for product approval by regulatory agencies.