FDA Approves G1’s Cosela to Prevent Damage from Chemotherapy

February 23, 2021 - FDA recently approved G1 Therapeutics’ Cosela a therapy intended to reduce the frequency of chemotherapy-induced bone marrow suppression in adults for extensive-stage small-cell lung cancer. 

Cosela, or trilaciclib, is authorized to be administered intravenously as a 30-minute infusion within four hours before the start of chemotherapy. It is the first FDA-approved therapy to provide protection from chemotherapy-induced myelosuppression.

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

“Today’s approval of Cosela will give patients a treatment option that can reduce the occurrence of a common, harmful side effect of chemotherapy,” Deisseroth continued.

Cosela may help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6, a type of enzyme, FDA explained. 

FDA based its approval of Cosela on three randomized, double-blind, placebo-controlled studies involving patients with extensive-stage small-cell lung cancer. Researchers randomly assigned nearly 245 patients to receive either an infusion of Cosela or placebo before chemotherapy.

Researchers compared the two groups for the proportion of patients with severe neutropenia, which is a very low count of white blood cells, and the duration of severe neutropenia in the first cycle of chemotherapy. 

FDA noted that in all studies, patients who received Cosela had a lower chance of having severe neutropenia compared to patients who received a placebo. And patients who received Cosela and had severe neutropenia had it for a shorter time than patients who received a placebo. 

The majority of adverse reactions reported with Cosela were mild to moderate in severity. The most common adverse reactions occurred in less than 10 percent of patients and included fatigue, hypocalcemia, hypokalemia, hypophosphatemia, headache, and pneumonia. 

Serious adverse reactions occurred in 30 percent of patients receiving Cosela.

“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,” Jack Bailey, chief executive officer at G1 Therapeutics, said in a press release following the approval. 

“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,” Bailey continued. 

Non-small cell lung cancer is the most common type of lung cancer, accounting for 84 percent of all lung cancer diagnoses. Experts estimate that there will be about 235,760 new cases of lung cancer and nearly 131,880 deaths from lung cancer in 2021. 

Bone marrow is particularly susceptible to chemotherapy damage, FDA stated. The bone marrow makes red blood cells, white blood cells, and platelets that transport oxygen, fight infection, and stop bleeding.

When damaged, the bone marrow produces fewer of these cells, which increases the risk of infection and bleeding, among other problems. Cosela may help protect the normal bone marrow cells from the harmful effects of chemotherapy. 

“Quite often, people diagnosed with extensive-stage small cell lung cancer rely on chemotherapy to not only extend their lives, but also to acutely alleviate their symptoms,” Bonnie J. Addario, co-founder and board chair of the Go2 Foundation for Lung Cancer, said in the G1 Therapeutics press release.

“G1 shares our organization’s goal to improve the quality of life of those diagnosed with lung cancer and to transform survivorship among people living with this insidious disease. We are thrilled to see new advancements that can help improve the lives of those living with small cell lung cancer,” Addario concluded.