Metastatic Breast Cancer Therapy Gains Fast Track Designation
The FDA granted Fast Track Designation to gedatolisib, to treat patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy, according to a press release from the manufacturer.
The company plans to finalize the protocol of its Phase 3 clinical trial in the first quarter of 2022.
Gedatolisib has a different mechanism of action and pharmacokinetic properties from other currently approved therapies, according to the release.
The manufacturer also announced plans to begin two phase 2 clinical trials to evaluate gedatolisib in HR+/HER2- breast cancer patients 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 other will evaluate up to 15 patients with early-stage breast cancer with gedatolisib, in combination with palbociclib and letrozole.
The two trials will take place at sites already participating in a trial that is screening patients with the HER2 and PI3K test.
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By MD /alert Staff