25 Aug 2020
Posted in Pharma
Trilaciclib’s regulatory advancement signals a significant moment for supportive cancer care, says GlobalData
Trilaciclib’s new drug application (NDA) acceptance signals a significant moment for cancer patients that need support with chemotherapy-induced toxicities – further highlighted by the fact that the therapy has been granted Breakthrough Therapy Designation by the US FDA. By being able to preserve bone marrow and immune system function, Trilaciclib’s mechanism of action (MoA) of CDK4/6 inhibition represents an opportunity to address the problem of myelosuppression at a more upstream level, compared to the current rescue interventions such as increasing production of neutrophils or red blood cells in patients, which impart a reactive solution, says GlobalData, a leading data and analytics company.
Vinie Varkey, MSc, Senior Healthcare Analyst at GlobalData, comments: “Effects of chemotherapy induced myelosuppression can include patients experiencing anemia and fatigue, as well as increased risk of infection and bleeding. The chemotherapy regimen may be limited or temporarily stopped to remedy the situation, but this can greatly affect a patient’s quality of life. If trilaciclib obtains FDA approval, it may mean that patients who receive this therapy can continue with life-saving chemotherapy regimens.”
Current treatment options have various limitations; for example, treatment of chemotherapy induced neutropenia with granulocyte colony-stimulating factors is known to cause bone pain in some patients. For patients with chemotherapy-induced anaemia, treatments such as transfusion is associated with the risk of causing infection. Such complications can lead to increased hospitalizations and cost to the healthcare system.
Varkey concludes: “It is in this context that trilaciclib could serve as an effective intervention strategy to prevent myelosuppression and aim to fill the gap created by current treatment options. The company also plans to evaluate this therapy in patients with colorectal cancer, as well as in patients with neoadjuvant breast cancer. If all goes well in terms of regulatory expectations for these additional indications, it is likely that trilaciclib will play a pivotal role in improving the quality of life for these patients.”