Expanded Access Policy
PMV Pharmaceuticals, Inc. (PMV) is a clinical-stage company dedicated to advancing innovative therapies for the treatment of cancer. In general, new therapeutics must be reviewed and approved by a regulatory authority, such as the U.S. Food and Drug Administration (FDA), before they become commercially available. Investigational drug products that have not yet been approved by FDA may, or may not, be effective as a treatment, and the use of such investigational products may cause unexpected serious side effects.
We understand that some patients may seek access to investigational products before they are approved by regulatory authorities. In such cases, access to an investigational product can be done through participation in clinical trials or through expanded access.
Wherever possible, we encourage patients to participate in clinical trials which offer the safest and best opportunity for patients to access an investigational product before regulatory approval. Clinical trials are research studies designed to evaluate whether a new therapeutic is safe and effective for patients. Data generated by clinical trials are then evaluated by regulatory authorities to determine whether the investigational product can be approved for commercialization.
In rare cases, if a patient has a life-threatening condition or serious disease and does not qualify for a clinical trial and has exhausted all available treatment options, PMV may consider providing access to an investigational product outside of a clinical trial through a process called expanded access.
Requests for expanded access are evaluated on a case-by-case basis. Making an expanded access decision is complex and takes into consideration a number of factors related to the patient’s circumstances and the scientific and medical information available for the investigational product at the time of the request.
While PMV aims to be as comprehensive as possible when considering expanded access requests, we must ensure that access to investigational product can be provided in a fair manner that complies with current regulatory guidelines, while upholding ethical principles, promoting good clinical practice, and minimizing potential risks to patients. Factors considered when evaluating expanded access requests include, but are not limited to, the following:
- The investigational product is currently being evaluated in a clinical study.
- The patient has a serious, life-threatening condition or disease with no viable treatment options.
- The patient’s enrollment in a clinical trial is not possible.
- There must be sufficient evidence that the potential benefit to the patient justifies the potential risks of treatment with the investigational product, based on currently available information for the investigational product.
- Granting expanded access for the requested use must not interfere with clinical trials that could support an investigational product’s clinical development or regulatory approval.
Requesting Expanded Access:
We encourage patients to first discuss eligibility for a clinical trial with their treating physician.
If a treating physician believes expanded access may be the only option for a patient, the physician may submit an inquiry or a formal request for expanded access on behalf of the patient to PMV by email to firstname.lastname@example.org. This will allow the treating physician to work with PMV’s clinical and medical experts to determine the best course of action.
PMV will acknowledge receipt of expanded access questions or requests from a licensed physician within five (5) business days of receipt. Submitting a request or receiving PMV’s acknowledgement of receipt of a request does not guarantee that expanded access will be granted. A request for expanded access can only be considered if the patient’s treating physician provides the required medical information and is fully committed to and is supportive of the requested treatment.
If a request is granted by PMV, the applicable regulatory authority in the jurisdiction where the request originated, or FDA in the United States, must grant final approval before PMV can ship the investigational product to the requesting physician.
Physicians located in the U.S. may find additional information regarding expanded access to investigational products by visiting the FDA website: Expanded Access: Information for Physicians.
For information on PMV clinical trials, please visit www.clinicaltrials.gov.