IMM2902
IMM2902 is a recombinant bispecific monoclonal antibody. The indication is the use of IMM2902 in patients with HER2-expressing advanced solid tumors, breast cancer and gastric cancer.
Immuneonco will consider providing a requesting physician with pre-approval access to a specific investigational drug, for the treatment of an individual patient outside of a clinical trial, when certain conditions are met. These conditions include the following:
- The patient has a serious or life-threatening illness or condition and is either no longer responsive to or no longer able to tolerate any available treatment option.
- The investigational drug is in active clinical development with sufficient data available to determine an appropriate dose and schedule for the patient’s specific condition.
- 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.
- Making the investigational drug available will not negatively impact or delay the conduct of clinical trials or regulatory review or approval of the investigational drug for broader patient access.
- Adequate supply of the investigational drug is available.
Immuneonco is committed to evaluating all requests in a fair and equitable manner. All requests must be submitted by the patient’s treating physician. Immuneonco may require more detailed information in order to fully evaluate a request. Each request will be given careful consideration by Immuneonco whose decisions are final.
Physicians seeking pre-approval access for patients with no alternative treatment options should submit their requests to the mailbox (info@immuneonco.com). We regularly monitor this mailbox and will use our best efforts to acknowledge each submitted request within 7 working days after receipt.
To learn more about the EA policy by Immuneonco, please visit www.immuneonco.com.