has announced accelerated approval from the US Food and Drug Administration (FDA) for EPKINLY (epcoritamab-bysp) to treat adult patients with relapsed or refractory follicular lymphoma (R/R FL). A T-cell engaging bispecific antibody for subcutaneous administration, EPKINLY is indicated for R/R FL patients following treatment with two or more lines of previous therapy. The gold standard of business intelligence.
The approval is based on the overall response rate and response durability elicited by the trial asset. Continued approval will follow on the regulator validating the clinical benefit of the antibody in a confirmatory trial(s). Developed jointly by AbbVie and in a oncology partnership, epcoritamab will be commercialised by the parties in the US and Japan.
AbbVie will manage global commercialisation of the asset. The FDA’s decision is based on the Phase I/II EPCORE NHL-1 clinical trial, which assessed EPKINLY’s safety and efficacy in 127 patients with a median of three previous therapies, 70% of whom had double refractory disease. Access the most comprehensive Company Profiles on the market, powered by GlobalData.
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However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form According to the findings, an overall % response r.
