Deciphera believes that the best route to enable all patients to access medicines is through the established applicable regulatory approval process and commercial availability of that medicine. However, Expanded Access Programs (EAP) provide a pathway to gain access to investigational medicines for patients who are facing serious and life-threatening circumstances for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available but their physician feels they should still try the investigational medicine. As part of our sustained commitment to patients, Deciphera may be able to provide access to an investigational medicine, under certain limited conditions, through our EAP.
Deciphera’s main objective when initiating an EAP is to equitably serve the patient community with compassion and dignity. Deciphera aims to accomplish this by thoughtfully balancing requests for treatment with the need to protect patient safety and ensure ethical and compliant access to the medicine.
Deciphera will only consider EAPs when the following conditions are met:
- The patient suffers from a serious or immediately life-threatening disease or condition.
- There are no other suitable treatment options and the patient is no longer responsive to, or able to tolerate, these therapies; or the patient has a relevant medical condition, that in the opinion of the physician, makes an approved agent unsuitable for the patient.
- The patient is not eligible or unable to participate in any ongoing clinical study of the investigational product.
- There is sufficient evidence indicating that the potential benefits of expanded access outweigh the collective potential risks to the patient (and such risks are not unreasonable in the context of the disease or condition to be treated).
When considering an EAP, Deciphera considers the following:
- The investigational product is in active clinical development in one or more clinical studies.
- There is sufficient clinical and safety data about use of the investigational drug to identify an appropriate dosing regimen and suitable formulation.
- A sufficient supply of the investigational product exists and can reasonably accommodate the likely duration of treatment for the patient, considering the needs of clinical trials and other patients in treatment.
- Expanded access to the investigational product will not compromise or interfere with clinical development of the product, including the initiation, conduct or completion of clinical trials.
How to Apply to Deciphera’s EAP
Deciphera has established an EAP for our investigational drug, ripretinib, in countries where it has not received regulatory approval for use and is allowed by local health authorities. For a patient to participate in our EAP, the treating physician must make a formal request on behalf of the patient by sending an email to firstname.lastname@example.org. Receipt of this request will be acknowledged within one business day.
For a patient to receive access to ripretinib through Deciphera’s EAP, the patient must meet the following criteria:
- Has locally advanced unresectable or metastatic gastrointestinal stromal tumors (GIST).
- Does not meet the criteria to participate in ongoing clinical trials studying ripretinib.
- Had received treatment with at least two FDA-approved therapies.
Upon receipt of a request for access to an investigational medicine, the requesting physician will receive more details about the guidelines around participation in the Deciphera EAP. Participation in the EAP will end once the investigational medicine is approved and becomes commercially available in the patient’s country.