MacroGenics Inc. (NASDAQ:MGNX) announced that during its latest mid-cycle communication with the FDA, the agency notified them that it will not be holding the Oncologic Advisory Committee consultation regarding the company’s Biologics License application to review its drug margetuximab.
MacroGenics has been collaborating with FDA regarding BLA for margetuximab
However, the FDA confirmed that it will continue participating in meeting the Prescription Drug User Fee Act goal date for the review of an application that will be on December 18, 2020. MacroGenics CEO and President Scott said that since the company submitted the BLA for margertiximab it has been working together with the US FDA to address questions from the agency as they come. He added that the company will continue working closely with the FDA to potentially deliver margetuximab as a possible treatment alternative for HER2-positive metastatic breast cancer patients.
The company is seeking FDA approval for the margetuximab, which is an Fc-engineered, investigational monoclonal antibody targeting HER2. Margetuximab is a potential treatment of pre-treated metastatic HER2-positive breast cancer patients in combination with chemo.
Margetuximab to offer HER2 blockade
HER2 is found on some cancer cells surfaces, and it is related to poor prognosis and aggressive disease. Usually, around 15% to 20% of breast cancer patients are HER2 positive, and antibody-based therapies such as margertuximab have improved significantly the outcomes of HER2-positive breast cancer patients becoming standard of care in onset and late stage of the disease. Despite the progress in various therapies, metastatic breast cancer remains a disease with unmet needs. The HER2 blockade has been recommended as a treatment for refractory and relapsed disease patients.
MacroGenics designed margetuximab to offer a HER2 blockade, and it has the same HER2 binding as well as anti-proliferative effects such as trastuzumab. Equally, the company has engineere3dd margertuximab to enhance the immunity system’s engagement through the MacroGenic Fc Optimization technology.
Also, the company is evaluating the combination of margetuximab with checkpoint blockade. The second and third Phase MAHOGANY study, which is currently ongoing, is evaluating the combination for treating HER2 positive gastroesophageal cancer.