FDA Approves Drug To Protect Against Chemo-Induced Myelosuppression

The US Food and Drug Administration have approved a novel drug that offers protection from chemotherapy-induced myelosuppression. The drug called trilaciclib (Cosela, G1 therapeutics) is administered four hours before starting chemotherapy as an 30-minute intravenous infusion. It is specifically indicated for the treatment of patients with extensive-stage small cell lung cancer (ES-SCLC) receiving chemotherapy. The drug which is an inhibitor of the cyclin-dependent kinase 4/6 enzyme protects normal bone marrow cells from the harmful effects of chemotherapy.

Albert Desisseroth M.D, PhD, supervisory medical officer in the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research said, “For patients with extensive-stage SCLC, protecting bone marrow function may help make their chemotherapy safer and allow them to complete their course of treatment on time and according to plan.”

Trilaciclib: First Drug Of Its Kind

The manufacturer said that trilaciclib is the first and only therapy designed to help protect bone marrow (myeloprotection) when given before chemotherapy.

Myelosupression is life-threatening and one of the most severe adverse effects of chemotherapy. In myelosuppression, the count of red blood cells, white blood cells and platelets decreases. Hence, it increases the infection risk and can lead to severe anemia and/or bleeding.

The company said, “These complications impact patients' quality of life and may also result in chemotherapy dose reductions and delays. To date, approaches have included the use of growth factor agents to accelerate blood cell recovery after the bone marrow injury has occurred, along with antibiotics and transfusions as needed. By contrast, trilaciclib provides the first proactive approach to myelosuppression through a unique mechanism of action that helps protect the bone marrow from damage by chemotherapy.”

Clinical Trials

Three randomized, double-blind, placebo-controlled studies were conducted that involved 245 patients with ES-SCLC. These patients were administered chemotherapy regimens that were based on the combination of etoposide and carboplatin (with or without the immunotherapy atezolizumab) or regimens that were based on topotecan.

The patients were randomly assigned to receive trilaciclib or placebo before receiving chemotherapy.

The results showed that the patients who had received an infusion of trilaciclib before receiving chemotherapy had a lower chance of developing severe neutropenia (low white blood cell count) when compared with patients who received a placebo. Additionally, those patients who did develop severe neutropenia had shorter duration than those who received placebo.

The most common side effects seen with trilaciclib included fatigue, low levels of potassium, phosphate, and calcium in blood, elevated liver enzymes- aspartate aminotransferase, headache, and pneumonia.

In the future, clinical trials will be conducted by the company to assess the effect of trilaciclib on disease progression or survival with at least a 2-year follow up.

Source-Medindia