Nuvalent is committed to researching and developing novel new drug candidates that are intended to prioritize selectivity in order to minimize adverse events, drive durable responses, and ultimately bring precisely targeted therapies to patients with cancer. Our goal at Nuvalent is to ensure the safety and efficacy of our investigational therapies and advance them through the clinical trial and regulatory processes with a sense of responsible urgency. It is through clinical trials and the regulatory review and registration process with regulators that follows that we expect to make our therapies more widely available for patients who need them. Nuvalent encourages patients to speak with their treating physicians about treatment options and, when appropriate given their condition, participate in clinical trials. We understand that there may be certain circumstances when a patient may not meet the eligibility criteria to participate in a clinical trial or a clinical trial is not available and the patient may have exhausted all available treatment options.
Expanded Access is a potential pathway for patients diagnosed with a serious and/or life-threatening disease or condition to gain access to an investigational product for treatment outside of a clinical trial when no comparable or satisfactory alternative therapy option is available. Terminology for describing Expanded Access varies and can include: Pre-Approval Access (PAA), Managed Access Program (MAP), Early Access Program (EAP), and Compassionate Use.
Nuvalent will consider providing a requesting physician access to a specific Nuvalent investigational drug for the treatment of an individual patient in the EAP program outside of a clinical trial when certain conditions are met. These conditions include but are not limited to the following:
- The patient has a serious or potentially life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option i.e., has exhausted all available treatment options
- A benefit-risk analysis, based on both the available clinical data as well as the requesting physician’s assessment of the individual patient’s condition and history, supports making the investigational drug available
- The patient is ineligible for enrollment into or unable to access ongoing clinical trials
- Fulfillment of the investigational medicine will not jeopardize the development program that may lead to broader public access to the investigational product through marketing authorization
- Providing access to the investigational drug is allowed under applicable local laws and regulations
- There is adequate supply of the investigational drug
- The treating physician has experience with the investigational product and has the capability, including adequate facilities, equipment, and personnel, to administer the investigational drug and provide any care for the patient needed in connection with the investigational drug in a safe manner
We continually evaluate the benefit-risk profile of each of our investigational drugs based on evolving clinical data. Each compound is different and Nuvalent may decide not to make an investigational drug available under this policy.
All requests are considered in a fair and just manner in accordance with our guiding principles. All requests must be submitted by the patient’s treating physician. If a patient submits a request, Nuvalent will respond to the patient asking them to have their physician submit the request. Submitting a request does not guarantee access will be granted; decisions regarding access are made at Nuvalent’s sole discretion. Furthermore, the fact that an investigational drug is made available for the treatment of a particular patient does not mean it will be made available in response to requests for other patients whose circumstances and medical histories may be different. Requests will be considered on a case-by-case basis.
Physicians seeking Expanded Access for an individual patient should submit their requests to medicineaccess@clinigengroup.com. We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 3 business days.
