The US Food and Drug Administration (FDA) has granted fast rrack 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,” said Tim Pearson, chief executive officer of Carrick Therapeutics.
“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,” he added.
Samuraciclib in combination with fulvestrant is currently being evaluated in a Phase IIa study for CDK4/6i resistant HR+, HER2- metastatic breast cancer. Meanwhile, samuraciclib in combination with chemotherapy for the treatment of TNBC is currently undergoing IND-enabling studies.
New data is expected to be presented at the European Society for Medical Oncology Congress in September.