On November 6th, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the National Medical Products Administration stated that AbbVie's application for the launch of a new drug, a concentrated solution for injection of cetuximab, has been accepted. This innovative therapy was previously listed by industry media Evalute as one of the top ten potential heavyweight therapies for 2023.
According to publicly available information from AbbVie, EPCRITAMAB (trade name: Epkinly) is a CD3/CD20 bispecific antibody that has been approved by the US FDA for the treatment of diffuse large B-cell lymphoma and follicular lymphoma. EPCoritamab is jointly developed by AbbVie and Genmab, and the two companies will share commercialization responsibilities in the United States and Japan. AbbVie will be responsible for further global commercialization of the product.
In May 2023, EPCRITAMAB received its first accelerated approval from the US FDA for the treatment of relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). In June of this year, EPCRITAMAB was once again approved by the FDA for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who had previously received systemic therapy beyond line 2.