Press Release

January 23, 2022
1 min read

FDA grants fast track designation to gedatolisib for breast cancer subset


Press Release

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The FDA granted fast track designation to gedatolisib for treatment of certain patients with breast cancer.

The designation applies to use of the agent by individuals with hormone receptor-positive, HER2-negative metastatic breast cancer whose disease progressed on cyclin-dependent kinase (CDK) 4/6 inhibitor therapy.

The FDA's fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.

Gedatolisib (Celcuity Inc.) is a pan-PI3 kinase/mTOR inhibitor.

Results of an ongoing phase 1B trial showed gedatolisib in combination with palbociclib (Ibrance, Pfizer) and endocrine therapy induced a robust response rate among patients with ER-positive, HER2-negative advanced breast cancer, according to a Celcuity-issued press release. The regimen also appeared well-tolerated.

A phase 3 trial is planned.

“There is an urgent need for better treatment options for [patients with hormone receptor-positive, HER2-negative metastatic breast cancer] whose disease progressed after treatment with a CDK4/6 inhibitor and endocrine therapy,” Brian Sullivan, CEO and co-founder of Celcuity, said in the release. “We are very encouraged by the clinical data for gedatolisib and believe that fast track designation will facilitate our efforts to advance its development for patients as quickly as possible."