It was announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy and granted a priority review.
Trilaciclib is a first-in-class investigational therapy designed to preserve bone marrow and immune system function during chemotherapy and improve patient outcomes.
The FDA based the priority review on results of three randomised, double-blind, placebo-controlled clinical trials that administered trilaciclib before chemotherapy in SCLC patients.
As a result, chemotherapy-induced myelosuppression was significantly reduced in these patients.
In these trials, trilaciclib significantly reduced chemotherapy-induced myelosuppression, and patients receiving trilaciclib experienced fewer dose delays/reductions, infections, hospitalisations, and need for rescue therapies compared to patients receiving chemotherapy alone.
The FDA grants priority review to applications for potential therapies that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
“There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur,” said Raj Malik, M.D., Chief Medical Officer and Senior Vice President, R&D. “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 has also been granted Breakthrough Therapy Designation by the FDA.
“While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations,” said Jared Weiss, M.D., Lineberger Comprehensive Cancer Center, University of North Carolina Chapel Hill, NC. “Preventing bone marrow damage proactively is an opportunity to improve the quality of life of patients receiving chemotherapy for small cell lung cancer and reduce costly rescue interventions.”
Myelosuppression is the result of damage to bone marrow stem cells and is one of the most common side effects of chemotherapy.
Myelosuppression can lead to serious conditions such as anaemia, neutropenia or thrombocytopenia, which have broad ranging clinical, patient experience and economic impacts on ongoing cancer treatment and overall outcomes.
Source: G1 Therapeutics