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G1’s Cosela scores FDA nod to ease chemotherapy’s harmful effects on bone marrow

Despite the ever-growing use of targeted oncology drugs, chemotherapy is still widely used in lung cancer—and it still comes with potentially severe side effects. G1 Therapeutics just won FDA approval for a therapy that can help combat one of the most serious.

G1’s Cosela scored a green light to reduce the bone marrow damage that can come along with chemo. Given ahead of certain chemotherapy regimens to patients with extensive-stage small-cell lung cancer, Cosela is the first medicine designed for that purpose.

As the biotech points out, chemotherapy doesn’t only kill cancer cells. While it’s an “effective and important weapon” for fighting cancer, the regimens also kill healthy cells. Chemotherapy’s damage to bone marrow, or myelosuppression, can increase the risk of infection, anemia and more.

While “effective and widely used” in extensive-stage SCLC, chemotherapy regimens are “highly myelosuppressive and can lead to costly hospitalizations and rescue interventions,” G1 Therapeutics CEO Jack Bailey said in a statement. The company’s new drug “will help change the chemotherapy experience” for those battling the disease.

Last summer, G1 struck a co-promotion deal with Boehringer Ingelheim to market the drug in the U.S. in small cell lung cancer. The company also partnered with Simcere Pharma to sell it in China, Hong Kong, Macau and Taiwan “across all indications.”

The company expects the drug to be available by early March through its specialty distribution network. Cosela is a 30-minute infusion administered within four hours of the start of chemotherapy.

In several phase 2 studies, patients who received the drug before chemo saw lower rates of myelosuppression and less need for supportive care than patients who received chemotherapy alone. G1 scored a priority review for the medicine last summer. 

The biotech is also testing the drug as a chemo companion in triple-negative breast cancer.