TAIHO ONCOLOGY, INC. — PRE-APPROVAL ACCESS TO INVESTIGATIONAL MEDICINES
Taiho Oncology, Inc. (“Taiho”) is committed to helping patients with cancer obtain access to new treatments. While we believe this is best accomplished through participation in clinical trials, we recognize that this is not always possible for every cancer patient. In such situations, Taiho may be able to provide pre‑approval access to an investigational drug through our Expanded Access Program. Expanded Access, also known as Compassionate Use, is the use of an investigational medical product intended to diagnose, monitor or treat a patient's disease or condition, prior to FDA approval and outside of use in a clinical trial. Taiho accepts requests for pre‑approval access to investigational cancer medicines from physicians only.
To be eligible for access to an investigational medicine, a physician must apply and certify that the patient for whom the application is being submitted meets the following criteria*:
- The patient is suffering from a serious or life‑threatening malignancy and has received available standard treatments without success
- The patient is not eligible to participate in any ongoing clinical study of the Taiho investigational agent
- The medicine requested is part of an active ongoing clinical development program at Taiho Oncology (US) as described on our website: www.taihooncology.com/us under the tab for ‘Our Science’
- Provision of the investigational agent will not interfere with the ongoing Taiho development program, and the potential benefits to the patient outweigh the potential risks
Receipt of a completed application form will be confirmed electronically within 24 hours. Following receipt of the application, Taiho may request additional information as needed to complete our assessment. Once all of the required information is provided to Taiho for review by our internal medical experts, a decision for pre‑approval access will be communicated within 5‑7 business days.
For general information about publicly and privately supported clinical trials conducted around the world, please visit: https://clinicaltrials.gov.
For additional information about the FDA's current Expanded Access policies, requirements for enrolling in Expanded Access programs, and steps you can take to get more information, please visit: https://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/default.htm.
* Note that meeting these criteria does not guarantee access to any investigational product.