Expanded Access

Summit is committed to improving patients' quality of life, extending their potential lifespan, and addressing serious unmet medical needs. We aim to provide access to our medicines at the right time and in the way that is most beneficial to patients. We believe participation in our ongoing clinical trials is the safest and most effective path, and we encourage patients to speak with their physician about available trial options. 

Our investigational medicine, ivonescimab, is currently being studied in clinical trials across North America, Europe, and Japan. More information about these trials is available at ClinicalTrials.gov. 

Summit does not solicit or recommend expanded access requests. At this time and in exceptional circumstances, Summit will consider a treating physician's request for single-patient expanded access to ivonescimab in the United States and Canada for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), who have received prior epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) therapy.

Expanded Access Considerations:

All requests are reviewed case-by-case by Summit's Expanded Access Review Board (EARB)
and must meet all of the following criteria: 

• The patient has a serious or immediately life-threatening disease or condition
• No comparable or satisfactory alternative therapy is available
• The patient cannot enroll in an ongoing clinical trial
• The potential benefit to the patient justifies the potential risks
• Providing access will not interfere with ongoing trials or regulatory timelines for ivonescimab 

To Submit a Request: 

1. Expanded access requests must be submitted by the patient's treating physician — patients cannot apply directly.
2. Download and complete Summit's Expanded Access Request Form (FRM-MA-009a). FDA Form 3926 (US) or the Health Canada Special Access Program form (Canada) may be accepted in lieu of FRM-MA-009a.
3. Include the treating physician’s curriculum vitae with the submission.
4. Email the completed form and supporting documents to EAP@smmttx.com. 

Please do not include patient-identifying information (provide patient initials, sex, and age in years instead). Incomplete submissions will not be processed. 

Nothing on this page creates any obligation on the part of Summit to grant expanded access to any patient, physician, or institution. Summit retains sole and absolute discretion to approve, deny, suspend, or terminate any expanded access request or arrangement at any time, for any reason not prohibited by law, and reserves the right to revise this policy at any time.