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FDA Grants Priority Review to Trilaciclib in Chemotherapy-Treated Small Cell Lung Cancer

*August 2020*

The FDA has granted Priority Review to the New Drug Application (NDA) for trilaciclib (G1T28) for the treatment of patients with small cell lung cancer (SCLC) who are receiving chemotherapy, G1 Therapeutics announced in a press release. The Prescription Drug User Fee Act has an action date of February 15, 2021.

There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur,” said Raj Malik, MD, chief medical officer and senior vice president, R&D, in a statement. “If approved, trilaciclib would be the first proactively administered myelopreservation therapy that is intended to make chemotherapy safer and reduce the need for rescue interventions, such as growth factor administrations and blood transfusions.”

Trilaciclib, the first-in-class investigational agent, is used to preserve bone marrow and immune system function during chemotherapy treatment in order to improve outcomes for patients with SCLC. Myelosuppression, which occurs as a result of damage to bone marrow stem cells, is 1 of the most common side effects of chemotherapy and can lead to serious conditions, including anemia, neutropenia, or thrombocytopenia. This can have broad-ranging clinical patient experience and economic impacts on ongoing treatment and outcomes. Read more.