Crenolanib

Indicated For

FLT3-mutated acute myeloid leukemia

About This Medication

# Arog Pharmaceuticals Crenolanib Patient Assistance Program Guide ## About This Program Arog Pharmaceuticals offers a **compassionate use program** for crenolanib (crenolanib besylate), a specialized medication used to treat certain types of acute myeloid leukemia (AML) with specific genetic mutations. This program is designed to provide access to crenolanib for patients with serious, life-threatening illnesses who have exhausted all available standard therapies and have no other viable treatment options. ## What is Crenolanib? Crenolanib is a type I tyrosine kinase inhibitor that targets specific genetic mutations in blood cancer cells. It works by blocking the activity of mutated proteins (FLT3, PDGFRα, and other targets) that drive certain types of AML. The medication has been used to treat over 350 patients and has an established safety record. Crenolanib is typically taken orally at a dose of 100 mg three times daily, though dosing may vary based on your specific treatment plan. ## Who Qualifies for This Program? To be eligible for Arog Pharmaceuticals' crenolanib compassionate use program, you must meet ALL of the following criteria: - Have a serious, life-threatening illness (specifically AML with one of the following genetic mutations): - FLT3-ITD (internal tandem duplication within FMS-like tyrosine kinase 3) - FLT3-TKD (point mutations within the tyrosine kinase domain of FLT3) - PDGFRA-D842V (point mutation in position 842 of platelet-derived growth factor receptor alpha) - PDGFRA amplification - Have exhausted all available standard therapies used to treat your disease - Have no other viable therapy options available - Not be eligible for or enrolled in an active clinical trial - Have documented genetic testing confirming one of the above mutations ## Income Eligibility The search results do not specify income thresholds or financial eligibility requirements for Arog Pharmaceuticals' crenolanib compassionate use program. **Income limits may not apply** to this particular program, as compassionate use programs are often evaluated on a case-by-case basis regardless of financial status. However, you should contact Arog Pharmaceuticals directly to confirm whether financial need is considered in the application process. ## Insurance Requirements The program details regarding insurance coverage are not specified in available information. Compassionate use programs typically evaluate patients individually regardless of insurance status. Contact Arog Pharmaceuticals to discuss your specific insurance situation and how it may affect your eligibility. ## How to Apply While specific application procedures are not detailed in the available information, the following general steps apply to Arog's crenolanib compassionate use program: 1. **Consult Your Healthcare Provider**: Your oncologist or treating physician must initiate the request on your behalf. They will need to document that you meet all eligibility criteria. 2. **Gather Required Documentation**: Your medical team will need to compile: - Proof of your AML diagnosis - Genetic testing results confirming FLT3 or PDGFRA mutations - Documentation of all prior treatments attempted - Evidence that no other viable treatment options remain - Your current medical records and treatment history 3. **Obtain Institutional Review Board (IRB) Approval**: Before crenolanib can be provided, your healthcare institution's Institutional Review Board or Independent Ethics Committee must review and approve the compassionate use request. 4. **Submit Your Request**: Your healthcare provider will submit the complete application package to Arog Pharmaceuticals for individual patient evaluation. 5. **Contact Information**: For specific application procedures and to submit your request, contact Arog Pharmaceuticals directly. Ask your healthcare provider for the current contact information and application portal. ## Processing Timeline The exact processing time for compassionate use requests is not specified in available information. However, because these requests are evaluated on a **patient-by-patient basis**, approval timelines may vary depending on the complexity of your case and the completeness of your application. Your healthcare provider should contact Arog Pharmaceuticals to discuss expected timelines for your specific situation. ## Medication Delivery Once approved, crenolanib will be provided through the compassionate use program. The specific delivery method (mail, pharmacy pickup, etc.) should be confirmed with Arog Pharmaceuticals at the time of approval. ## Treatment Duration and Reauthorization Crenolanib is provided through the compassionate use program while Phase 3 clinical studies are ongoing. The program is designed to limit supply such that it does not interfere with the needs of ongoing clinical trials. Your treatment duration and any reauthorization requirements should be discussed with your healthcare provider and Arog Pharmaceuticals. ## What If Your Application Is Denied? If your initial request is denied, ask Arog Pharmaceuticals for specific reasons. Common reasons for denial include: - Not meeting the genetic mutation criteria - Availability of other viable treatment options - Eligibility for an active clinical trial - Insufficient documentation of prior treatment attempts If denied, discuss with your oncologist whether additional information can be provided or whether your clinical situation has changed. ## Important Disclaimer This guide provides general information about Arog Pharmaceuticals' crenolanib compassionate use program based on available public information. Program details, eligibility criteria, and procedures may change. This information is not a guarantee of program eligibility or approval. Always consult with your healthcare provider and contact Arog Pharmaceuticals directly for the most current and accurate information about program requirements, application procedures, and your individual eligibility. Your healthcare provider is your best resource for understanding whether crenolanib may be appropriate for your specific medical situation.

Program information last verified: March 30, 2026