Carrick Therapeutics, an oncology-focused biopharmaceutical company discovering and developing highly differentiated therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designations to samuraciclib in combination with fulvestrant for CDK4/6i resistant HR+, HER2- advanced breast cancer and samuraciclib in combination with chemotherapy for the treatment of locally advanced or metastatic triple negative breast cancer (TNBC).
The FDA’s decision to grant Fast Track designations for both samuraciclib combinations underscores the urgent need for innovative therapies that can significantly improve HR+, HER2- advanced breast cancer and locally advanced or metastatic TNBC patient outcomes. This is a meaningful milestone for our development in samuraciclib as we work to advance innovative combination treatment approaches for patients who have few treatment options available today.
said Tim Pearson, Chief Executive Officer of Carrick Therapeutics.
The FDA’s Fast Track program is designed to facilitate and expedite the development of investigational treatments that demonstrate a potential to address unmet medical needs in serious or life-threatening conditions. Programs with Fast Track designation can benefit from early and frequent communication with the FDA in addition to a rolling submission of the marketing application.
Samuraciclib in combination with fulvestrant is currently being evaluated in a Phase 2a study for CDK4/6i resistant HR+, HER2- metastatic breast cancer and the Company expects to present the new data from the ongoing study at the European Society for Medical Oncology (ESMO) Congress 2021 in September. Meanwhile, samuraciclib in combination with chemotherapy for the treatment of treatment of TNBC is currently undergoing IND-enabling studies.