FDA grants accelerated approval to epcoritamab-bysp for relapsed or refractory follicular lymphoma
The agency authorized Genmab's bispecific T-cell engager for adults with follicular lymphoma that has returned or stopped responding after prior treatment.
On June 26, 2024, the FDA granted accelerated approval to epcoritamab-bysp, marketed as Epkinly by Genmab US, Inc. The drug is a bispecific CD20-directed CD3 T-cell engager approved for adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.1
The approval covers patients whose follicular lymphoma has come back or did not respond to at least two earlier rounds of systemic treatment, based on the FDA's published indication language.
No additional details on dosing, safety findings, or post-marketing commitments appear in the FDA record supplied. Readers seeking those specifics should consult the full prescribing information or the underlying clinical trial data once available.
Fact check notes
- Checker's noteThe claim about the accelerated approval pathway allowing earlier access based on surrogate endpoints is an unsupported addition not found in the provided source, though it is generally accurate FDA policy.
- Sentence removed
The agency's accelerated approval pathway allows earlier access to therapies for serious conditions based on surrogate endpoints, though the source document provided here does not list the specific trial data, response rates, or confirmatory trial requirements tied to this authorization.
unsupported: This general description of the accelerated approval pathway is not stated in the provided source document; it's an added explanatory claim not found in the text.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Where the check questioned a sentence, its note is shown above. Not investment advice.