The maximum number of years that gratinumab cannot be used for more than

Glofitamab uses a fixed course of treatment in the treatment of relapsed or refractory diffuse large B-cell lymphoma (non-Hodgkin's lymphoma) rather than indefinite long-term maintenance medication. This is one of the important features that makes it different from traditional targeted therapies or immune checkpoint inhibitors. According to the current usage guidelines and product instructions approved in Europe and the United States, the treatment of gaffetuzumab is usually a maximum of 13 infusions, and the cycle is approximately 12 to 14 weeks, which means that the treatment course limit itself is limited and is not an open medication regimen. Therefore, from a clinical perspective, gaffetuzumab is not designed to be used long-term and for many years.

The rationality of this treatment model is that its mechanism of action mainly eliminates CD20-positive B cells through transient activation ofT cells. The efficacy can usually be judged to be significantly improved within the first course of treatment, and sustained remission can be observed in most patients. Long-term use of gaffetuzumab may lead to potential toxic risks caused by long-term activation of the immune system, such as cytokine release syndrome (CRS), immune-related low leukocytes, etc. Therefore, in the globally approved instructions for use, extended use beyond the prescribed period is not recommended.

Currently, there are no studies or guidelines to support the continuous use of gaffetuzumab as maintenance therapy for several years, mainly due to safety considerations and lack of clinical necessity. If a patient does not achieve complete remission or develops disease progression after initial treatment, doctors will usually evaluate whether to switch to other treatment options, such as CAR-T, allogeneic hematopoietic stem cell transplantation, or a combination of other immunotherapies, rather than repeatedly extending the use of gaffetuzumab. It can be inferred from this that based on clinical experience and drug design concepts, the "maximum service life" of gaffetuzumab generally does not exceed one year, and the entire dosing cycle is usually completed within a few months. It is a representative of a new generation of dual-antibody drugs that aims to be short-course, highly effective, and maintenance-free.

Reference materials:https://www.drugs.com/glofitamab.html