HUTCHMED is committed to developing targeted therapies and immunotherapies for the treatment of cancer and immunological diseases.
Our prolific in-house novel drug discovery and development engine has been the main driver of creating and developing our portfolio of drug candidates over the past two decades.
Expanded Access Policy
HUTCHMED is committed to making investigational products available to seriously ill patients or patients with a life threatening disease or illness who have exhausted all available treatment options. Our goal is to encourage clinical trial participation in order to further the science behind patient care. Clinical trials are research studies conducted to determine if an investigational medicine is safe and effective for patients. However, in the event clinical trial participation is not available or feasible, when patients do not qualify for clinical trials and have exhausted all available medical options, HUTCHMED may consider providing an investigational agent outside of a clinical trial, or before it is approved by regulators as part of an individual or group based expanded access program.
Expanded Access for surufatinib
HUTCHMED has commenced an Expanded Access Program (EAP) in the United States with surufatinib for patients with Neuroendocrine Tumors, who cannot be treated with available medical options or in clinical trials. Details about the FDA approved protocol, eligibility criteria, and how to request Expanded Access can be found below. Information about the surufatinib EAP can also be found on ClinicalTrials.gov, NCT04814732.
Who is Eligible
A treating physician, who is able to comply with the requirements that are stated in this policy, may request information about how to apply for access to HUTCHMED investigational agents by contacting the company.
This policy describes HUTCHMED's corporate policy regarding expanded access programs on how physicians may be able to access our investigational agents on behalf of a patient in medical need if that patient does not qualify for participation in available clinical trials and otherwise meets the criteria of this policy.
This policy applies to provision of access to a HUTCHMED investigational agent that is not approved for any purpose in the country in which the patient and the physician are resident. It also includes the time period between regulatory approval of an investigational agent and its commercial availability in such country.
HUTCHMED is committed to evaluate all requests in a fair and equitable manner, however, there is no guarantee that every request will be fulfilled. All requests must be submitted by the patient’s treating physician. HUTCHMED may require more detailed information in order to fully evaluate the appropriateness of request. The requesting physician must:
Each request will be given careful considerations on a case by case basis by HUTCHMED whose decisions are final.
How to request Expanded Access
Physicians should provide name, affiliation, contact detail, investigational agent and brief description when seeking expanded access for patient. Requests can be submitted via email to: ExpandedAccess@hmplglobal.com. We will use our best efforts to acknowledge each submitted request within 3 business days from receipt.
HUTCHMED Approach to Expanded Access
The following criteria must be met in order for a patient to be considered eligible for Expanded Access:
Any use of HUTCHMED investigational agent in an expanded access program must be done in accordance with local laws and regulations governing such program, and in accordance with HUTCHMED policies and procedures.
Unless prohibited by local regulations, the expanded access program will be terminated by HUTCHMED once the regulatory agency approves the investigational agent for commercial use.
HUTCHMED may revise this policy at any time.