Dataset Information

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

ABSTRACT: On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Approval was based on data from SOPHIA, a multicenter, randomized, open-label, active controlled study comparing margetuximab with trastuzumab, in combination with chemotherapy. The primary efficacy endpoint was progression-free survival (PFS) by blinded independent central review. SOPHIA demonstrated a 0.9-month difference in median PFS between the two treatment arms [5.8 vs. 4.9 months, respectively; stratified HR, 0.76 (95% confidence interval: 0.59-0.98; P = 0.0334)]. Overall survival (OS) was immature at the data cut-off date of September 10, 2019. Infusion-related reactions (IRR) are an important safety signal associated with margetuximab plus chemotherapy. In SOPHIA, 13% of patients treated with margetuximab plus chemotherapy reported IRRs, of which 1.5% were grade 3. The most commonly reported adverse drug reactions (>10%) with margetuximab in combination with chemotherapy were fatigue/asthenia, nausea, diarrhea, vomiting, constipation, headache, pyrexia, alopecia, abdominal pain, peripheral neuropathy, arthralgia/myalgia, cough, decreased appetite, dyspnea, IRR, palmar-plantar erythrodysesthesia, and extremity pain. Overall, the favorable risk-benefit profile for margetuximab when added to chemotherapy supported its approval for the intended indication.

SUBMITTER: Royce M

PROVIDER: S-EPMC9012688 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

Royce Melanie M Osgood Christy L CL Amatya Anup K AK Fiero Mallorie H MH Chang C J George CJG Ricks Tiffany K TK Shetty Krithika A KA Kraft Jeffrey J Qiu Junshan J Song Pengfei P Charlab Rosane R Yu Jingyu J King Kathryn E KE Rastogi Anshu A Janelsins Brian B Weinberg Wendy C WC Clouse Kathleen K Borders-Hemphill Vicky V Brown Lindsey L Gomez-Broughton Candace C Li Zhong Z Nguyen Thuy Thanh TT Qiu Zhihao Z Ly Anh-Thy AT Chang Suyoung S Gao Tingting T Tu Chi-Ming CM King-Kallimanis Bellinda B Pierce William F WF Chiang Kelly K Lee Clara C Goldberg Kirsten B KB Leighton John K JK Tang Shenghui S Pazdur Richard R Beaver Julia A JA Amiri-Kordestani Laleh L

Clinical cancer research : an official journal of the American Association for Cancer Research 20220401 8

On December 16, 2020, the FDA granted regular approval to margetuximab-cmkb (MARGENZA), in combination with chemotherapy, for the treatment of adult patients with HER2-positive (HER2+) metastatic breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease. Approval was based on data from SOPHIA, a multicenter, randomized, open-label, active controlled study comparing margetuximab with trastuzumab, in combination with chemotherapy. The pr ...[more]

PMID: 34916216

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Dataset Information

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

Publications

FDA Approval Summary: Margetuximab plus Chemotherapy for Advanced or Metastatic HER2-Positive Breast Cancer.

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