Expanded Access

Investigational medicines for patients who need hope

Chimerix Approach to Expanded Access

In cases where a clinical trial is not an option, a patient may qualify for access to a Chimerix investigational medicine through an expanded access pathway. Treating physicians and patients should note that investigational medicines do not have established safety and efficacy, so all potential risks and benefits should be carefully evaluated before seeking expanded access to unapproved medicines. The following criteria must be met for a patient to be considered for an Expanded Access program:

  • Providing investigational medicine through expanded access will not compromise the initiation, conduct or completion of a clinical study program that is required for approval of investigational medicines.
  • The patient does not meet eligibility criteria related to current or past eligibility for certain Chimerix sponsored trials.
  • The patient has a serious or immediately life-threatening disease for which no alternative therapies are currently available.
  • There is adequate clinical evidence of a positive benefit to risk profile for the investigational medicine in the disease indication, suggesting that a clinically meaningful benefit may be expected and that the benefits outweigh any potential risks.
  • The expanded access program is authorized for the requested indication.
  • There are adequate supplies of the drug available for use.

Physicians seeking expanded access to a Chimerix investigational product on behalf of their patient should review and access the information provided below on the US Expanded Access Program and the Managed Access Programs in select countries. If additional information is needed, an inquiry can be submitted to [email protected]. Chimerix will promptly acknowledge receipt of requests from treating physicians, generally within 24-48 hours of receiving the request for information. Requests must not include the patient’s name or specific identifying information. There is no guarantee that an expanded access request will be granted. Physicians who receive a Chimerix investigational medicine for their patients through the Expanded Access Program must comply with all applicable laws and regulations, contractual conditions, safety reporting required by regulatory agencies, and protection of intellectual property. This policy is subject to change. Chimerix will revisit the policy periodically and amend it as appropriate.

ONC201

The ONC201 Expanded Access Program (EAP) has been made available in the United States and the ONC201 Managed Access Program (MAP) has been made available in the United Kingdom (UK), Spain, Germany, and Australia.

In the US, the EAP is open in select hospitals. A list of centers that are either open for enrollment in the US or in the process of initiating the program can be found on clinicaltrials.gov along with their contact information. Patients and their families can reach out directly to these centers to discuss eligibility, treatment options and enrollment timelines, as enrollment activities must be completed by the treating physician and their respective institutions in collaboration with Chimerix before a patient can be treated.

In the UK, Spain, Germany, and Australia, requests for Managed Access must be submitted by a qualified physician in those countries. The physician must assess whether the patient meets the eligibility criteria for the program. If you are a physician located in the UK, Spain, Germany or Australia, please contact [email protected].

For patients who live in a country where there is not a MAP available, they have the option to travel to the US. and enroll in the ONC201 EAP under the treatment of a US physician, or travel to another country where the MAP has opened and enroll under the treatment of a physician in that country. If you are a physician and have further questions on the EAP or MAP Programs at Chimerix, please contact [email protected].

ONC206

Chimerix does not provide expanded access for ONC206

Clinical Trials
  • How do patients apply to the ONC201 US Expanded Access Program?

    Requests for Expanded Access need to be submitted by a US based physician familiar with the patient’s medical history. Families and patients may reach out directly to participating hospitals to evaluate treatment options. Contact information for these centers can be found on clinicaltrials.gov: click here.

  • How do patients apply to the ONC201 Managed Access Program?

    The ONC201 Managed Access Program is currently available in the UK, Spain, Germany, and Australia.  Families and patients should reach out directly to their treating physician in those countries to evaluate treatment options. Requests for ONC201 through the Managed Access Program must be submitted by the patient’s responsible treating physician located in one of those countries. Physicians can access the requirements for the MAP by contacting [email protected].

  • How can I find out if a patient qualifies for the ONC201 Expanded Access Program?

    Patients and caregivers who are interested in our investigational medicine should first inquire with their physician if the patient would be eligible for a Chimerix enrolling clinical trial. If a patient is eligible for a Chimerix enrolling clinical trial, they will not be eligible for the US Expanded Access Program or one of the Managed Access Programs. Eligibility criteria and a list of participating hospitals for Chimerix’s clinical trials and for the US Expanded Access program are available on clinicaltrials.gov: click here. Physicians located in countries with a Managed Access Program can access the requirements by contacting [email protected].

  • Is there an age requirement to participate in the ONC201 Expanded Access Program?

    There is no age requirement for the ONC201 Expanded Access Program. There is a minimum body weight required to participate; all patients must be ≥ 10kg.

  • Does the ONC201 Expanded Access Program include newly diagnosed patients? Does it include patients in progression?

    For patients who do not qualify for a clinical trial and meet the other eligibility criteria for consideration in one of the EAP/MAP programs, the program may allow DIPG patients to start ONC201 as soon as 14 days after completion of radiation therapy, regardless of whether their disease has progressed or not. Patients who have a glioma diagnosis other than DIPG must have completed frontline radiation and had subsequent disease progression, as well as meet other EAP/MAP eligibility criteria, including being positive for the H3K27M mutation.

  • What is the cost to the patient for the ONC201 Expanded Access Program?

    Chimerix provides ONC201 free of charge to participating hospitals, and hospitals are not allowed to charge for the ONC201 investigational medicine. However, the cost of medical care for the patient may vary, depending on insurance and the local hospital. Please contact one of the participating centers to discuss the cost you may incur from your care provider.

How does Chimerix use the information submitted? 

Chimerix will use the information submitted to evaluate requests for access to its investigational medicines, and as described in its Privacy Policies.

How does Chimerix protect information submitted to its Expanded Access Program?

Chimerix has in place appropriate privacy and security policies which are intended to ensure, as far as reasonably possible, the security and integrity of all our information, including information submitted by you, whether the information is your personal information or pertains to another individual (e.g., the patient). However, as previously noted, requests for expanded access should not include patient identifiable information.  For more information about Chimerix’s processing of personal data, including how, why, and on what lawful bases Chimerix processes personal data, please read our Privacy Notice.