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Association details:
| Biomarker: | HR positive |
|---|---|
| Cancer: | HER2 Negative Breast Cancer |
| Drug: | gedatolisib (PF-05212384) (mTOR inhibitor, PI3K inhibitor, mTORC1 inhibitor, mTORC2 inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Celcuity Announces FDA Breakthrough Therapy Designation for Gedatolisib for Treatment of HR+/HER2- Metastatic Breast Cancer
Published date:
07/18/2022
Excerpt:
Celcuity Inc...announced that the U.S. Food and Drug Administration (FDA) has granted gedatolisib Breakthrough Therapy designation for the treatment of patients with HR+/HER2- metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and a non-steroidal aromatase inhibitor....Celcuity's breakthrough application was supported by data from a Phase 1b study that assessed the safety, tolerability and clinical activity of gedatolisib in combination with palbociclib and fulvestrant in patients with HR+/HER2- metastatic breast cancer whose disease progressed during treatment with a CDK4/6 therapy and an aromatase inhibitor.
Source:
Title:
Celcuity Receives FDA Fast Track Designation for Gedatolisib in HR+ / HER2- Metastatic Breast Cancer and Provides Corporate Update
Published date:
01/18/2022
Excerpt:
...Celcuity...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to the Company's lead drug candidate, gedatolisib, for the treatment of patients with HR+/HER2- metastatic breast cancer after progression on CDK4/6 therapy.
