Healthcare Professionals & Patients
Using science to make a difference in patients’ lives
Genmab Global Medical Affairs plays a key role in the creation and dissemination of data to support the value of our products for all our stakeholders. Our goal is to ensure the safe and appropriate use of our investigational products.
Taking an ethical and transparent approach, we ensure we are acting in the best interest of patients and helping to bridge the gap between clinical development and delivery.
Providing access to medicine means giving a sense of hope
At Genmab, patients and their families are at the heart and soul of the company. And we believe clinical trials are the primary route for patients with serious and life-threatening diseases who are looking for access to investigational medicines.
Eligible patients may be able to access medicines prior to their approval or launch through the Genmab Pre-Approval Access Program.
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
The Pre-Approval Access Program serves 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
- 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 pre-approval access (PAA) once the medicine has shown acceptable tolerability and activity in patient populations with high unmet needs.
Criteria for consideration of a request for PAA
The following criteria must be met for a request to be considered for PAA:
- 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 the 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 healthcare provider (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 PAA
Requests for access must be made voluntarily by the patient’s HCP. 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 (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 by 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:
- Date of request
- Requesting HCP’s name, contact information, address (including country) and professional qualifications
- Name of the requested Genmab investigational medicine, the therapeutic indication and intended treatment plan
- 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
Genmab reserves the right to revise this policy at any time.
We believe our current approach to early patient access, as outlined above, is consistent with the objectives of the Right to Try Act.
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