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The web links in this directory are public information provided to the Foundation and the acknowledgement times listed are the number of days or hours for a company to acknowledge receipt of request, not to make a decision. Data contained in this directory is provided either directly by the company or by ClinicalTrials.gov for the companies listed in this directory.
The Expanded Access listings provided on this website are limited to those companies currently in the Company Directory and include listings for expanded access which are Available, Temporarily Not Available and Approved for Marketing, which in some cases includes treatments which have not yet reached the market. In addition, many companies are willing to consider expanded access requests even if they do not show active Expanded Access Listings in this directory. Contact the company to explore the possibility of individual access to an investigational therapy.
Phone Number & Email
Expected Application Timeframe5 business days
Quizartinib is an experimental product being developed by Daiichi Sankyo that has not been approved yet by the FDA for relapsed or refractory FLT3-ITD mutated AML. The main objective of this program is to provide treatment with quizartinib as monotherapy to patients with relapsed or refractory FLT3-ITD mutated AML who are not eligible to participate in our current clinical trials. Expanded access treatment with quizartinib as monotherapy is currently available in the United States only, and will consist of 28-day continuous cycles. However, treatment may be placed on hold or permanently discontinued by the Sponsor at any point for reasons not limited to drug supply shortage, marketing authorization decline, or safety concerns.
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
DBV Technologies, Inc.
Expected Application Timeframe1 business day
Debiopharm International S.A.
Available Therapies via Single-Patient EA
Head & neck cancer
Debio 1143 is a potent, orally available, inhibitor of IAPs (Inhibitor of Apoptosis Proteins) that displays immunomodulatory properties making it a natural candidate for combination with Immune Checkpoint Inhibitors. In addition, like other members of the class, Debio 1143 promotes apoptosis of cancer cells by mimicking the activity of the natural Second Mitochondrial-derived Activator of Caspases (SMAC). Through this dual mode of action, Debio 1143 is expected to improve cancer patient treatment outcomes in combination with immunotherapy, chemotherapy and/or radiotherapy respectively investigated in NSCLC, H&N cancer and Ovarian Cancer.