FDA Grants Priority Review to Trilaciclib to Treat Patients with SCLC


The FDA granted priority review to the new drug application for trilaciclib for patients with small cell lung cancer being treated with chemotherapy.

The FDA has granted priority review to the new drug application (NDA) for trilaciclib to treat patients with small cell lung cancer (SCLC) being treated with chemotherapy, according to G1 Therapeutics, the developer of the agent.

A prescription drug user fee act (PDUFA) action date has been set by the FDA for February 15, 2021. Previously, trilaciclib was granted breakthrough therapy designation by the FDA.

“There are currently no available therapies to protect patients from chemotherapy-induced toxicities before they occur,” Raj Malik, MD, chief medical officer and senior vice president at R&D, said in a press release. “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 NDA for trilaciclib was supported by compelling myelopreservation data observed in 3 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 significantly reduced chemotherapy-induced myelosuppression, and patients receiving trilaciclib also experienced fewer dose delays/reductions, infections, hospitalizations, and need for rescue therapies compared to patients receiving chemotherapy alone.

Notably, in the NDA acceptance letter the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss this application.

“While undergoing chemotherapy, many patients experience significant myelosuppression, become fatigued and susceptible to infection, and often require transfusions and growth factor administrations,” Jared Weiss, MD, of the Lineberger Comprehensive Cancer Center at the University of North Carolina Chapel Hill, NC, said in the release. “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.”

Trilaciclib is also being evaluated in other cancer types, including in a randomized trial of women with metastatic triple-negative breast cancer. Preliminary data from the trial showed that trilaciclib improved overall survival (OS) when administered in combination with chemotherapy compared with chemotherapy alone; G1 Therapeutics indicated it plans to present final OS data from this trial in the fourth quarter of 2020.

Moreover, trilaciclib is being evaluated in neoadjuvant breast cancer as part of the I-SPY 2 TRIAL, and the company anticipates initiating a phase 3 trial in patients treated with chemotherapy for colorectal cancer in the fourth quarter of 2020.


G1 Therapeutics Announces Acceptance and Priority Review of NDA for Trilaciclib for Patients with Small Cell Lung Cancer [news release]. Research Triangle Park, NC. Published August 17, 2020. Accessed August 17, 2020. https://markets.businessinsider.com/news/stocks/g1-therapeutics-announces-acceptance-and-priority-review-of-nda-for-trilaciclib-for-patients-with-small-cell-lung-cancer-1029508089#

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