05:02 AM EDT, 06/27/2024 (MT Newswires) -- Genmab A/S ( GMAB ) said late Wednesday that the US Food and Drug Administration approved Epkinly, or epcoritamab-bysp, for the treatment of adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.

This indication has been given the green signal under the FDA's accelerated approval program based on the treatment's response rate.

The company said continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.

The approval follows results from a phase 1/2 clinical trial evaluating the safety and preliminary efficacy of Epkinly in 127 adult patients who previously received a median of three lines of therapy, among other things.

The results showed an overall response rate of 82% and a complete response rate of 60%, including 67% of patients achieving minimal residual disease negativity.

Shares of the company were up 3.2% in after-hours activity on Wednesday.

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