FDA approves G1 Therapeutics’ Cosela for reducing chemotherapy-induced bone marrow suppression

G1 Therapeutics has achieved a significant milestone with the recent U.S. Food and Drug Administration (FDA) approval of Cosela (trilaciclib), a pioneering treatment designed to reduce bone marrow suppression caused by chemotherapy in adults. This approval marks a critical advancement in the treatment of extensive-stage small cell lung cancer (ES-SCLC).

Details of Cosela’s Impact and Usage:

Cosela is specifically approved to lessen the frequency of chemotherapy-induced bone marrow suppression in patients undergoing certain chemotherapy regimens, including those containing platinum/etoposide or topotecan. The FDA highlights that Cosela works by blocking the cyclin-dependent kinase 4/6 enzyme, which plays a key role in protecting bone marrow cells from chemotherapy damage.

Clinical Benefits and Trials:

The approval of Cosela is supported by data from three randomized, placebo-controlled trials. These studies demonstrated that patients pre-treated with Cosela experienced a clinically meaningful and statistically significant reduction in both the duration and severity of neutropenia—a common and severe side effect of chemotherapy. The trials also showed positive effects on reducing the need for red blood cell transfusions and other protective measures against myelosuppression. Cosela has been tested in combination with carboplatin/etoposide (plus/minus the immunotherapy atezolizumab) and topotecan chemotherapy regimens.

Statements from FDA and G1 Therapeutics:

Albert Deisseroth, supervisory medical officer in the Division of Non-Malignant Hematology at the FDA’s Center for Drug Evaluation and Research, emphasized the importance of Cosela’s approval, stating, “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.” Jack Bailey, CEO of G1 Therapeutics, highlighted Cosela’s role in transforming the chemotherapy experience, noting, “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.”

Administration and Availability:

Cosela is administered intravenously as a 30-minute infusion within four hours before the start of chemotherapy. This marks it as the first FDA-approved therapy providing multilineage protection from chemotherapy-induced myelosuppression.

The FDA’s approval of Cosela represents a significant breakthrough in supportive care for cancer patients, specifically those undergoing intensive chemotherapy for small cell lung cancer. By mitigating the severe impacts of bone marrow suppression, Cosela not only enhances the safety and efficacy of chemotherapy but also improves patient outcomes and quality of life during treatment.