Pre-Approval Access

Our Promise

At Genmab, patients and their families are at the heart and soul of the company and all our work is driven by the desire to improve the quality of life of patients and their families. We believe that the primary route for patients with serious and life-threatening illnesses to access investigational medicines is through clinical trials. However, in some cases, this is not an option and eligible patients may be able to access medicines prior to their approval or launch through our Pre-approval Access Program (PAA). This program refers to the use of a Genmab investigational medicine outside of our clinical trials and prior to its commercial availability.

Pre-Approval Access Program (PAA)

Genmab has adopted the term PAA as an umbrella term that includes several access mechanisms that may have slightly different names, such as: Named Patient Program, Authorization for Temporary Use, Compassionate Use, Expanded Access Program or others, depending upon geography and what may be allowed by local regulatory authorities.

Each investigational medicine will be evaluated to assess the introduction of a PAA once the medicine has shown acceptable tolerability and activity in patient populations with high unmet needs.

Criteria for Consideration of a Request for Pre-approval access

Genmab is committed to reviewing requests for Pre-Approval Access to its investigational medicines and the following criteria must be met for a request to be considered.

  • The patient suffers from a serious, debilitating or life-threatening illness or condition within the disease areas Genmab is investigating and the efficacy and safety data available at the time are sufficient to determine whether the potential clinical benefit to patient would likely outweigh the possible risks, including the outcome of the disease
  • The patient has exhausted all available therapies typically used to treat the disease and is no longer responsive to, or able to tolerate, these treatments. The patient does not qualify for ongoing clinical trials sponsored by Genmab due to eligibility criteria or geographic location
  • Providing access to the investigational therapy must not interfere with the completion of a clinical trial supportive of a Health Authority approval or compromise the potential development of the therapy Sufficient efficacy and safety data are available to indicate that the potential benefits of access to the investigational medicine in the disease condition may outweigh any potential risks
  • There is manufacturing capacity and adequate supply of the investigational therapy is available
  • The HCP must be qualified and practicing with expertise and facilities appropriate for monitoring, managing and reporting side effects of the investigational medicine
  • The HCP must obtain informed consent from the patient or his/her legal guardian(s) for treatment use of the investigational medicine
  • The HCP must supervise administration of the investigational medicine in line with Genmab’s defined access criteria (which in some countries may include a protocol for treatment use).

Making a Request for PRE-APPROVAL access

Requests for access must be made voluntarily by the patient’s treating HCP and can be made here (insert direct link to Genmab’s appropriate person). Requests cannot be made directly by an individual patient or a patient’s parent/legal guardian or caregiver.

Every request will receive a confirmation of receipt within (to be agreed with Genmab*) and a decision will be made and communicated as soon as possible, usually acknowledging receipt of a request within 48 hours.

All requests received at Genmab will be carefully reviewed on an individual, case-by-case basis by Genmab’s PAA Governance committee, which has sole approval authority.

The following information must be included in any request

  1. Date of request
  2. Requesting HCP’s name, contact information, address (including country), and professional qualifications
  3. Name of the requested Genmab investigational medicine, the therapeutic indication and intended treatment plan
  4. Medical rationale for the request, including an explanation why alternative therapies cannot be used and why the patient does not qualify for a clinical trial.

Patients and caregivers seeking information about access to our investigational medicines, either through a clinical trial or through Pre-approval access, please consult with your treating physician or alternatively visit the Genmab Medical Affairs webpage.

Genmab reserves the right to revise this Policy at any time.

We believe our current approach to early patient access, as outline above, is consistent with the objectives of the Right to Try Act.

For any questions regrinding Pre-Approval Access Programs at Genmab, please contact PreApprovalAccess@genmab.com.

You can read our Privacy Policy here.

 

*Cures 21st Century Act requirement