On May 28, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that during the recent mid-cycle communication with the U.S. Food and Drug Administration (FDA), the FDA notified the Company that it is no longer planning to hold an Oncologic Drugs Advisory Committee (ODAC) meeting to discuss the Biologics License Application (BLA) for margetuximab (Press release, MacroGenics, MAY 28, 2020, View Source [SID1234558601]). The FDA also stated it continues to anticipate meeting the Prescription Drug User Fee Act (PDUFA) goal date for the application review, which is December 18, 2020.
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"Since submitting the BLA for margetuximab, we have worked collaboratively with the FDA to answer the Agency’s questions as they arise," said Scott Koenig, M.D., President and CEO of MacroGenics. "We will continue to work closely with the Agency to potentially bring margetuximab as a treatment option to patients with HER2-positive metastatic breast cancer."
MacroGenics is seeking approval of margetuximab, an investigational, Fc-engineered, monoclonal antibody that targets HER2, for the treatment of patients with pre-treated metastatic HER2-positive breast cancer in combination with chemotherapy.
About HER2-Positive Breast Cancer
Human epidermal growth factor receptor 2 (HER2) is a protein found on the surface of some cancer cells that promotes growth and is associated with aggressive disease and poor prognosis. Approximately 15-20% of breast cancer cases are HER2-positive. Antibody-based therapies targeting HER2 have greatly improved outcomes of patients with HER2-positive breast cancer and are now standard of care in both early-and late-stage disease. However, metastatic breast cancer remains an unmet need and ongoing HER2 blockade is recommended for the treatment of patients with relapsed or refractory disease.
About Margetuximab
Margetuximab is an Fc-engineered, monoclonal antibody that targets the HER2 oncoprotein. HER2 is expressed by tumor cells in breast, gastroesophageal and other solid tumors. Margetuximab was designed to provide HER2 blockade and has similar HER2 binding and antiproliferative effects as trastuzumab. In addition, margetuximab has been engineered to enhance the engagement of the immune system through MacroGenics’ Fc Optimization technology. Margetuximab is also being evaluated in combination with checkpoint blockade. The Phase 2/3 MAHOGANY trial for the treatment of patients with HER2-positive gastroesophageal cancer is ongoing (NCT04082364). For more information please visit www.clinicaltrials.gov.