G1 Therapeutics has bagged approval for Cosela (trilaciclib) from the US Food and Drug Administration (FDA) for reducing bone marrow suppression caused by chemotherapy.
Cosela FDA approval is for its use in cutting down the frequency of chemotherapy-induced bone marrow suppression in adults who are undergoing certain types of chemotherapy for extensive-stage small cell lung cancer.
The chemotherapy for which Cosela can be used is a platinum/etoposide-containing regimen or topotecan-containing regimen.
According to the FDA, Cosela could help in protecting bone marrow cells from damage resulting from chemotherapy by blocking the cyclin- dependent kinase 4/6 enzyme.
Commenting on Cosela FDA approval, Albert Deisseroth – supervisory medical officer in the Division of Non-Malignant Hematology in the FDA Center for Drug Evaluation and Research, said: “For patients with extensive-stage small cell lung cancer, 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.
“Today’s approval of Cosela will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy.”
As per G1 Therapeutics, Cosela is intravenously administered as a 30-minute infusion within four hours before the start of chemotherapy. It is now the first FDA-approved therapy that helps in giving multilineage protection from chemotherapy-induced myelosuppression.
Cosela FDA approval has been driven by the results of three randomized, placebo-controlled trials. In the trials, patients subjected to Cosela before the start of chemotherapy had experienced clinically meaningful and statistically significant reduction in the duration and severity of neutropenia.
Data from the trials also indicated a positive impact on red blood cell transfusions and other myeloprotective measures.
The trials assessed Cosela in combination with carboplatin/etoposide (+/- the immunotherapy atezolizumab) and topotecan chemotherapy regimens.
Jack Bailey – CEO of G1 Therapeutics, commenting on Cosela FDA approval, said: “Chemotherapy is the most effective and widely used approach to treating people diagnosed with extensive-stage small cell lung cancer; however, standard of care chemotherapy regimens are highly myelosuppressive and can lead to costly hospitalizations and rescue interventions.
“Cosela will help change the chemotherapy experience for people who are battling ES-SCLC. G1 is proud to deliver Cosela to patients and their families as the first and only therapy to help protect against chemotherapy-induced myelosuppression.”