Access to Investigational Medicines
Our mission is to make a meaningful difference for people impacted by difficult-to-treat cancers and other diseases.
In order to bring new treatments to patients, we conduct clinical trials to assess the safety and efficacy of our investigational medicines. This information is submitted to regulatory agencies, such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and Health Canada, to enable approval for patient use.
Most patients access Zymeworks investigational medicines through participation in one of our clinical trials. However, we understand that there are seriously ill patients who will not be eligible for our clinical trials and may not have options for alternative therapies. Therefore, Zymeworks considers all requests for access to our pipeline of investigational medicines through Expanded Access or Compassionate Use.
Information for the patient
If you are a patient with questions, we encourage you to talk with your physician about available treatment options and reasons to consider an investigational medicine.
If you and your physician agree that Expanded Access is a treatment option, your physician can make the request on your behalf. As with every investigational medicine that has not been approved by a regulatory agency, such as the FDA, there may be risks associated with use.
You will be asked to agree to participate by signing an Informed Consent Form. For additional information on Expanded Access, US patients, caregivers and patient advocates may visit the FDA website Expanded Access: Information for Patients.
How We Evaluate Requests
Patients interested in seeking Expanded Access to a Zymeworks investigational medicine should talk to their physician. Requests on behalf of a patient can only be considered when initiated by a licensed physician who is experienced in the treatment of the patient’s disease.
Physicians can request Expanded Access for a Zymeworks investigational medicine by sending an email to: Zymeworks.EAP@earlyaccesscare.com. Requests must not include the patient’s name or specific identifying information. Zymeworks Expanded Access programs have transparent eligibility criteria, which will be reviewed, discussed and confirmed with the treating physician prior seeking the required approvals. Investigational medicine will be distributed to the site only once all approvals are in place.
At Zymeworks, we are committed to developing therapies to help as many patients as possible, and all requests will be carefully and individually considered. In general, a written response will be provided to the requesting physician within 2 business days of receipt of all medical documentation required to assess patient eligibility. In some cases, additional consultation and discussion may be needed and a response may require additional time. Making a request does not guarantee access to an investigational medicine by Zymeworks.
How to Submit a Request
- The patient’s condition is serious or life-threatening and there is no satisfactory alternative therapy
- The patient is not eligible for participation in an ongoing clinical trial of the investigational medicine
- There is sufficient safety and efficacy data available at the time to support a reasonable potential to provide a benefit to the patient with an acceptable level of risk
- Providing the investigational medicine does not interfere with timely completion of clinical trials that could lead to broader patient availability
- There is an adequate supply of the investigational medicine to support clinical trials and the Expanded Access request, until and if the medicine becomes approved and available by prescription
- Expanded Access is permitted under applicable laws and regulations
Zymeworks will send to the treating physician a Letter of Agreement (Letter) outlining responsibilities. The physician will be responsible for collecting and submitting clinical data as specified by the Letter, during the treatment period and in any post-treatment follow-up period.
The physician will be responsible for ensuring all local legal, regulatory and Health Authority requirements are met, including Investigational Review Board or Ethics Committee approval, delivering appropriate informed consent, and reporting of adverse events. By signing the Letter of Agreement, the treating physician agrees to fulfill all the responsibilities outlined in the Letter.
In the U.S. physicians may find additional information on access to investigational medicines outside of a clinical trial by visiting the FDA website Expanded Access: Information for Physicians.
Non-U.S. physicians must follow local laws and regulations appropriate for the country originating the request.
Expanded Access Program Closure
Expanded Access programs will close around the time that the investigational medicine has been approved and is broadly available in the patient’s country. For this reason, and other reasons that may currently be unforeseeable, Zymeworks reserves the right to restrict access or discontinue an Expanded Access program at any time.