FDA OKs G1 Therapeutics' Cosela To Reduce Bone Marrow Suppression

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The U.S. Food and Drug Administration approved a new therapy to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for small cell lung cancer (SCLC) when it has spread beyond the lungs.

G1 Therapeutics' Cosela (trilaciclib) was approved as the first and only therapy in its class to help protect bone marrow cells from damage caused by chemotherapy by inhibiting cyclin-dependent kinase 4/6, a type of enzyme. The drug is given intravenously before chemotherapy to protect bone marrow function.

Cosela is expected to be commercially available through G1 Therapeutics' specialty distributor partner network in early March 2021.

Chemotherapy is the most effective and widely used approach to treat people diagnosed with extensive-stage SCLC. However, chemotherapy regimens are highly bone marrow suppressive and can lead to costly hospitalizations and rescue interventions.

Bone marrow suppression results in reduced white blood cells, red blood cells and platelets. Chemotherapy drugs are designed to kill cancer cells but can damage normal tissues as well. The bone marrow is particularly susceptible to chemotherapy damage.

Cosela will offer treatment that can reduce the occurrence of a common, harmful side effect of chemotherapy.

Cosela approval is based on data from three randomized, double-blind, placebo-controlled studies in a total of 245 patients with extensive-stage SCLC. They received either an infusion of Cosela in their veins or a placebo before chemotherapy.

In all three studies, patients who received Cosela had a lower chance of having severe neutropenia (a very low count of white blood cells called neutrophils), compared to patients who received a placebo. Even those who had severe neutropenia, had it for a shorter time.

The FDA had granted Cosela Breakthrough Therapy designation for the indication in 2019. G1 intends to initiate the post-approval clinical trial in 2022.

Approximately 30,000 small cell lung cancer patients are treated in the United States annually. SCLC, one of the two main types of lung cancer, accounts for about 10 to 15 percent of all lung cancers and about 70 percent of them will have cancer that has metastasized by the time they are diagnosed, according to the FDA.

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