On August 17, 2020, the FDA accepted a New Drug Application (NDA) for trilaciclib for small cell lung cancer (SCLC) patients being treated with chemotherapy. Trilaciclib is a first-in-class investigational therapy intended to preserve bone marrow and immune system function during chemotherapy and enhance patient outcomes. In 2019, trilaciclib received FDA Breakthrough Therapy Designation, and, in June 2020, the manufacturer submitted the NDA based on myelopreservation data from three randomized, double-blind, placebo-controlled clinical trials in which trilaciclib was administered prior to chemotherapy in patients with SCLC. 

In August 2020, the manufacturer received FDA Priority Review with the Prescription Drug User Fee Act date of February 15, 2021. The NDA for trilaciclib was supported by robust myelopreservation data observed in three randomized, double-blind, placebo-controlled clinical trials in which the agent was administered prior to chemotherapy treatment in patients with SCLC. In clinical trials, trilaciclib considerably diminished chemotherapy-induced myelosuppression, and patients receiving trilaciclib also experienced less dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared with patients receiving chemotherapy alone. 

In the NDA acceptance letter, the FDA also stated that it is currently not planning to hold an advisory committee meeting to discuss this application. This agent is also being evaluated for other types of cancer, including in a randomized trial of women with metastatic triple-negative breast cancer. Preliminary data from the trial showed that trilaciclib improved overall survival when administered in combination with chemotherapy compared with chemotherapy alone.

In the press release, Raj Malik, MD, chief medical officer and senior vice president, stated, “There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur. 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.”

The manufacturer is making trilaciclib available to SCLC patients in the U.S. who are unable to enter clinical trials and for whom there are no appropriate alternative treatments while the trilaciclib NDA is under regulatory review, pursuant to FDA’s expanded access program.
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