Expanded Access to Investigational Products Program Main Content
Expanded Access to Investigational Products
As an organization, Daiichi Sankyo’s mission is to provide our medicines to patients who need them. A medication must undergo well-designed and well-conducted clinical trials to evaluate its safety and efficacy, and to demonstrate that its potential benefit outweighs the possible risks for patients, before it can become available to patients by prescription.
Obtaining regulatory approval for marketing is the most efficient and rapid way to provide access to new medicines to the greatest number of patients who may benefit. Therefore, Daiichi Sankyo believes its resources should be directed toward sponsoring clinical trials that are likely to support the regulatory approval of an otherwise unapproved investigational product, or of a new indication for an already approved product, thereby offering the greatest benefit to at-risk patient populations.
We recognize, however, 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 may be able to arrange provision of an investigational product through an expanded access program (someti mes called “compassionate use” or “early access”). 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.
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.
For an overview of our investigational products, please visit our pipeline chart. Alternatively, you may visit www.clinicaltrials.gov and search for information on clinical trials sponsored by Daiichi Sankyo.
Who might be eligible for expanded access to a Daiichi Sankyo investigational product?
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 which typically occurs when Daiichi Sankyo has decided to seek marketing approval in at least one major market globally.
- 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. All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from Daiichi Sankyo (or our agent) within 5 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with Daiichi Sankyo.
For approved requests:
- Daiichi Sankyo will provide the investigational product at no charge to the requestor for a duration and frequency determined by the company.
- The requestor is responsible for reporting any safety issues associated with the use of the investigational product to Daiichi Sankyo and regulatory authorities as required.
- Daiichi Sankyo is not accountable for securing local ethics committee approval for expanded use of its investigational product.
If you are a patient who feels that expanded access to an investigational medicine may benefit you, please consult with your physician. Your physician must make this request on your behalf following the instructions below:
For physicians requesting expanded access to [fam-] trastuzumab deruxtecan
Daiichi Sankyo and AstraZeneca are diligently working together to bring [fam-] trastuzumab deruxtecan to patients as soon as possible and are committed to ensuring that once a patient has started on drug they are guaranteed continuous supply until they/their physician deems it is time to stop drug. We are prioritizing drug supply to our ongoing clinical development trials and to the approved indication, where applicable. Therefore currently, we are not offering access to [fam-] trastuzumab deruxtecan under a compassionate use/early access program. The timing and design of any EAP will be communicated in the future.
For information on ongoing clinical trials please refer to https://clinicaltrials.gov/.
As always, patients are our priority, please do not hesitate to contact us if you require additional information via firstname.lastname@example.org.
For physicians requesting expanded access to quizartinib (AC220):
The quizartinib (AC220) program is now closed to new patients. Quizartinib is approved for use in Japan under the brand name VANFLYTA® for the treatment of adult patients with relapsed/refractory FLT3-ITD AML. Quizartinib is investigational in all other countries. If you have any questions, please contact email@example.com.
For physicians requesting expanded access to pexidartinib:
The pexidartinib program is now closed to new patients. Pexdartinib is approved for use in the United States under the brand name TURALIO® for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. Pexidartinib is investigational in all other countries. If you have any questions, please contact firstname.lastname@example.org.
For physicians requesting expanded access to other Daiichi Sankyo investigational compounds other than [ fam-] trastuzumab deruxtecan, quizartinib or pexidartinib:
Please be aware that Daiichi Sankyo does not currently have formal expanded access programs for our other investigational products. On the basis of the above framework and criteria, we consider granting expanded access 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.
Overview of process
Physicians requesting expanded access to Daiichi Sankyo investigational products other than quizartinib should fill out the form and click “submit”. Daiichi Sankyo medical personnel, or our agent, will review the form for completeness and make a decision on the request.
If a decision is made to provide access to an investigational product, the requestor will be notified by Daiichi Sankyo as soon as possible with instructions for executing the Expanded Access Agreement. Upon full execution of the agreement, drug shipment coordination with the physician’s office will be scheduled.
Click here to access the form for requesting expanded access to Daiichi Sankyo investigational products other than quizartinib.
PP-US-ON-1107 07/20PP-US-ON-0851 10/19