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FDA Approves IV Tx for HER2 Breast Cancer – Margenza

December 29, 2020Winter Garden, FL
More catching up —
The FDA approved another specialty therapy earlier this month. The new approval is Margenza (margetuximab-cmkb) from MacroGenics and is indicated for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens. It the first HER2-targeted therapy to have improved progression-free survival (PFS) versus Herceptin (trastuzumab), when both are combined with chemotherapy.
Margenza is an infused therapy. Other 2020 approvals for HER2 breast cancer have been orals.Pricing was not announced at the time of approval.Product launch is targeted for March 2021.
Because of its anticipated high cost and a black box warning, Margenza will likely launch as yet another distribution product via a specialty pharmacy, direct-to-office/hospital.

MacroGenics Announces FDA Approval of Margenza  for Patients with Pretreated Metastatic HER2-Positive Breast Cancer


ROCKVILLE, MD, Dec. 16, 2020 (GLOBE NEWSWIRE) — MacroGenics, Inc., 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…..
Click here to read the full press release
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