Trilaciclib in Combination with Chemotherapy Receives FDA Fast Track Designation for Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer

The FDA has granted Fast Track Designation to trilaciclib (Cosela) for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).

The FDA has granted Fast Track Designation to trilaciclib (Cosela) for use in combination with chemotherapy for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).1

Trilaciclib is being evaluated in PRESERVE 2, a phase 3, placebo-controlled study in patients receiving first- or second-line gemcitabine and carboplatin chemotherapy for TNBC. The injection is intended to “help protect against myelosuppression, while chemotherapy targets cancer cells,” according to the Cosela website.1,2

“Fast Track designation underscores the urgent need for innovative drugs that can significantly improve TNBC patient outcomes,” said Raj Malik, MD, chief medical officer at G1 Therapeutics, in a press release. “It provides an important pathway to help expedite the development and regulatory review of COSELA in this indication. We look forward to working closely with the FDA as we advance this pivotal program in TNBC and continue to work to unlock the broader potential of this pipeline-in-a-molecule compound that we hope will help patients across multiple tumor types.”1

In February 2021, the FDA approved trilaciclib (Cosela) to reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving certain types of chemotherapy for extensive-stage small cell lung cancer (ES-SCLC). In clinical trials, trilaciclib, when given before chemotherapy, was found to lead to a significant decrease in most measures of multilineage chemotherapy-induced myelosuppression and the need for supportive care interventions.

The most common adverse effects of treatment with trilaciclib include fatigue; low levels of calcium, potassium and phosphate; increased levels of aspartate aminotransferase; headache; and pneumonia.

REFERENCES

1. G1 Therapeutics receives fast track designation from US Food and Drug Administration for Cosela™ (Trilaciclib) in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer. G1 Therapeutics. July 19, 2021. Accessed July 19, 2021. http://investor.g1therapeutics.com/news-releases/news-release-details/g1-therapeutics-receives-fast-track-designation-us-food-and-drug

2. Cosela. Cosela website. Accessed July 19, 2021. https://www.cosela.com/