Expanded Access to Investigational Products
Plexxikon strives to achieve our goal of developing personalized medicine through the process of sponsoring clinical trials and discovering new drug candidates. Information on clinical trials sponsored by Plexxikon is available on www.clinicaltrials.gov.
We recognize, however, that a patient might suffer from a serious or life-threatening disease or condition, where there is an unmet medical need that cannot be met by existing products, and enrollment into a clinical trial is not possible. In these cases, a treating physician can request the use of an investigational Plexxikon product prior to regulatory approval for that particular condition or indication, provided it is allowed by the applicable local laws.
The purpose of this policy is to describe the requirements and process for expanded access to Plexxikon’s investigational products to patients outside of a clinical trial.
This policy applies to Plexxikon’s investigational products that are not approved in the country from which the request originates. This may also include the period between regulatory approval of an investigational product and commercial availability in a country.
Any use of a Plexxikon investigational product outside of a clinical trial must be in accordance with local laws and regulations governing this use, including Plexxikon policies and procedures.
Plexxikon may decide not to provide an investigational product under this policy if the Company does not intend to market the product in the country from which the request originated.
For physicians requesting expanded access to pexidartinib, please visit the Daiichi-Sankyo website: https://dsi.com/expanded-access
For physicians requesting expanded access to Plexxikon investigational products other than pexidartinib
Plexxikon does not currently have formal expanded access programs for our other investigational products. On the basis of the below 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.
Who might be eligible for expanded access to a Plexxikon investigational product?
The following criteria are typically required before Plexxikon would consider patients eligible for expanded access to a Plexxikon investigational product.
- The patient suffers from a serious or life-threatening disease or condition, where there is a medical need that cannot be met by existing products.
- The benefit/risk profile is acceptable, as deemed by medical personnel of the company
- The patient is ineligible or unable to participate in any ongoing clinical study of the investigational product.
- The patient was withdrawn from a clinical study of the investigational product that was closed by Plexxikon and was deriving benefit at the time of withdrawal.
- 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 use of the investigational product in an expanded access protocol is compliant with local laws and regulations, as well as Plexxikon company policy.
All requests for expanded access (typically made by the treating physician) will be acknowledged by medical personnel from Plexxikon (or our agent) within 5 business days. Should the request be approved, the requestor must enter into an Expanded Access Agreement with Plexxikon.
The physician receiving a Plexxikon investigational product to treat a patient through Expanded Access use must be properly licensed and qualified to administer the product.
For approved requests:
- Plexxikon will provide the investigational product at no charge to the requestor for a duration and frequency determined by the company.
- Plexxikon will assist with drafting a treatment plan and consent risk language if requested
- The requestor is responsible for reporting any safety issues associated with the use of the investigational product to Plexxikon and regulatory authorities as required.
- Plexxikon is not accountable for securing local ethics committee (or, as applicable, regulatory authority) approval for expanded use of its investigational product.
- Plexxikon will determine whether the requestor or Plexxikon will be responsible for any applicable regulatory authority approval.
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 by emailing ExpandedAccess@plexxikon.com.