The margetuximab-cmkb combined with chemotherapy got approval from the Food and Drug Administration to treat metastatic HER2-positive breast cancer in adult patients who have received two or more previous anti-HER2 treatments in which at least one was meant for the metastatic disorder.
Efficiency was assessed in an open-label trial conducted in five hundred and thirty-six patients suffering from IHC 3+ or ISH-amplified HER2+ metastatic breast cancer who had their previous therapy with other anti-HER2 treatments.
Patients were grouped into two equal groups. One group received margetuximab with chemotherapy, and the other received trastuzumab with chemotherapy.
The primary efficiency result measures were progression-free survival (PFS). Further efficiency result measures were duration of response (DOR) and objective response rate (ORR).
In margetuximab arm, ORR was 22% with a median DOR of 6.1 months. On the other side, ORR was 16%, and median DOR was 6.0 months in the control arm.
The most common side effects of margetuximab combined with chemotherapy were fatigue, nausea, cough, diarrhoea, abdominal pain, vomiting, arthralgia, constipation and headache etc.
The recommended dose of margetuximab is 15 mg/kg through intravenous infusion. If both margetuximab and chemotherapy are administered on the same day, then, margetuximab can be administered directly after chemotherapy.
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Source: |
FDA |
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Link to the source: |
https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-margetuximab-metastatic-her2-positive-breast-cancer#:~:text=On%20December%2016%2C%202020%2C%20the,of%20which%20was%20for%20metastatic [Last accessed on: 6 January, 2021] |
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Original title of article: |
FDA approves margetuximab for metastatic HER2-positive breast cancer |
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Translated by: |
