FDA Brief: Fast Track Designation Granted for Gedatolisib in Metastatic Breast Cancer

By: JNCCN 360 Staff
Posted: Tuesday, February 8, 2022

The biotechnology company Celcuity recently announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation to its pan-PI3K/mTOR inhibitor gedatolisib for the treatment of patients with hormone receptor–positive, HER2-negative metastatic breast cancer after disease progression on CDK4/6 therapy. The company plans to finalize its phase III clinical trial design and protocol for this agent with FDA feedback in the first quarter of 2022. Site identification and feasibility activities for the phase III trial are ongoing.

Additionally, Celcuity announced plans to initiate two phase II clinical trials to evaluate gedatolisib in patients with hormone receptor–positive, HER2-negative breast cancer selected with a CELsignia PI3K Pathway Test. One trial will evaluate gedatolisib in combination with fulvestrant in up to 25 patients with metastatic breast cancer. The second trial will evaluate up to 15 patients with early-stage breast cancer with gedatolisib in combination with palbociclib and letrozole. Patients found to have hyperactive HER2 signaling will be eligible to receive treatment with an anti-HER2 therapy, and those with hyperactive PI3K signaling will be eligible to receive gedatolisib in combination with other targeted therapies. Patient enrollment is expected to begin for the two trials in late 2022.

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