AbbVie 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 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.
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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.
Injection site reactions, cytokine release syndrome and Covid-19 were among the most common adverse reactions reported in the trial.
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 latest development comes after the US FDA issued a complete response letter for the new drug application of AbbVie’s ABBV-951 to treat motor fluctuations in adult patients with advanced Parkinson’s disease.
