FDA OKs Cosela, first-in-class therapy to protect bone marrow after chemotherapy

The FDA has approved trilaciclib (Cosela, G1 Therapeutics) as the first therapy in its class to protect bone marrow in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer.

Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting the enzyme cyclin-dependent kinase 4/6, drug approval agency said in a press release.

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“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,” said Albert Deisseroth, M.D., Ph.D., supervisory medical officer in the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research.

Cosela is expected to be commercially available through G1’s specialty distributor partner network in early March, according to a press release issued by the drug's marker, G1 Therapeutics in Research Triangle Park, North Carolina.

The most serious and life-threatening side effect of chemotherapy is myelosuppression, or damage to the bone marrow, resulting in reduced white blood cells, red blood cells and platelets, said Jeffrey Crawford, M,D., Geller Professor for Research in Cancer in the Department of Medicine and Duke Cancer Institute.

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“Chemotherapy-induced myelosuppression may lead to increased risks of infection, severe anemia, and/or bleeding. These complications impact patients’ quality of life and may also result in chemotherapy dose reductions and delays,” Crawford said.

Treatment approaches to date 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, according to Crawford.

Cosela is administered intravenously as a 30-minute infusion within four hours prior to the start of chemotherapy.

Jack Bailey

“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,” said Jack Bailey, CEO of G1 Therapeutics, said in a press release. “COSELA will help change the chemotherapy experience for people who are battling ES-SCLC (extensive-stage small cell lung cancer."

The approval of the new treatment is based on data from three randomized, placebo-controlled trials that showed patients receiving Cosela prior to the start of chemotherapy had clinically meaningful and statistically significant reduction in the duration and severity of neutropenia.

The drug also produced a positive impact on red blood cell transfusions and other myeloprotective measures. The trials evaluated Cosela in combination with carboplatin/etoposide (plus or minus the immunotherapy atezolizumab) and topotecan chemotherapy regimens.

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