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MacroGenics Announces FDA Approval of MARGENZA™ for Patients with Pretreated Metastatic HER2-Positive Breast Cancer
MARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both
About this update from Macrogenics, Inc.
[{"type":"text","content":"MARGENZA (margetuximab-cmkb) is the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin® (trastuzumab), both combined with chemotherapy, in a head-to-head Phase 3 clinical trialMARGENZA is approved, in combination with chemotherapy, for the treatment of 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 diseaseProduct launch anticipated in March of 2021Conference call scheduled for Thursday, December 17, 2020 at 8:00 a.m. ET ROCKVILLE, MD, Dec. 16, 2020 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has approved MARGENZA, in combination with chemotherapy, for the treatment of 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. MARGENZA is the first product approved from MacroGenics’ promising pipeline. The approval was based on safety and efficacy results from the pivotal Phase 3 SOPHIA trial. “The approval of MARGENZA is an exciting milestone for MacroGenics and, more importantly, it brings a new treatment option to metastatic breast cancer patients. We are grateful for the patients who participated in this study, as well as their families, and everyone who played a role in helping MacroGenics reach this milestone,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “As we prepare for our first commercial launch and look forward to being able to deliver MARGENZA to patients, we continue to focus on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer with eight product candidates currently in clinical development.” The approval for MARGENZA was based on data from SOPHIA, a randomized Phase 3 clinical trial. The study, which included 536 patients, showed a statistically significant 24% reduction in the risk of disease progression or death with MARGENZA plus chemotherapy compared with trastuzumab plus chemotherapy (hazard ratio [HR]=0.76; 95% CI, 0.59-0.98; P=0.033; median PFS 5.8 vs 4.9 months). Th...