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 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 Genmab 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.
According to the findings, an overall % response rate of 82% was seen in subjects treated with EPKINLY, the trial’s primary endpoint. 60% experienced a complete response while 22% had a partial response.
At a median 14.8-month follow-up, the median duration of response had not been reached while sustained efficacy was observed in more than half of the responding patients.
AbbVie haematology therapeutic area head and vice-president Mariana Cota Stirner stated: “EPKINLY treatment has shown deep and durable responses for many patients. Subcutaneous dosing offers convenience, and EPKINLY can be given to patients without mandatory hospitalisation using a three-step-up dosing regimen.
“We believe that EPKINLY has the potential to be a core therapy in the treatment of multiple B-cell malignancies and furthers our company mission to advance research to raise standards of care for patients with cancer.”
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.