> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Approves MacroGenics’ Margenza
- URL: https://www.fdaweb.com/fda-approves-macrogenics-margenza/
- Published: 2020-12-17T12:00:00.000Z
- Updated: 2026-09-14T16:40:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148333

FDA has approved MacroGenic’s Margenza (margetuximab-cmkb), in combination with chemotherapy, to treat adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

A company [statement](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=0ahUKEwjaht7z2tXtAhXiw1kKHV4YAys4ChDF9AEIMTAA&url=https%3A%2F%2Fwww.globenewswire.com%2Fnews-release%2F2020%2F12%2F16%2F2146569%2F0%2Fen%2FMacroGenics-Announces-FDA-Approval-of-MARGENZA-for-Patients-with-Pretreated-Metastatic-HER2-Positive-Breast-Cancer.html&usg=AOvVaw3kvA7SHCXmJk68j7Uqzygf) says Margenza is the first HER2-targeted therapy to have improved progression-free survival versus Genentech’s Herceptin (trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 trial.

MicroGenics says the approval was based on safety and efficacy results from the Phase 3 SOPHIA trial and that Margenza will be available in 3/2021.