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Approvals Extend Use of Roche, AbbVie Drugs in Lymphoma

This week, the FDA approved EPKINLY plus rituximab and lenalidomide, making it the first bispecific antibody combination for relapsed or refractory follicular lymphoma after at least one prior systemic therapy.
Last year, the European Commission cleared a subcutaneous Lunsumio formulation for adults with relapsed or refractory FL, while AbbVie and Genmab's similarly acting drug had EU third-line clearance last year.
In sales terms, the CD20xCD3 class already shows that Epkinly generated $333 million for AbbVie and Genmab in the first nine months of 2025, while Columvi made $255 million.
In the short term, a United States decision on subcutaneous Lunsumio has been delayed but is expected before the end of the year, while Epkinly is delivered by subcutaneous injection versus Lunsumio's earlier intravenous infusion.
With the CELESTIMO readout delayed until next year, Roche says subcutaneous Lunsumio can be administered in as little as one minute and cites fixed‑duration dosing as a potential differentiator.

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Approvals extend use of Roche, AbbVie drugs in lymphoma

Patients in the US and EU with follicular lymphoma have new treatment options, thanks to new approvals for CD20xCD3 bispecifics Lunsumio and Epkinly.

1 day ago

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The Norfolk Daily News

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AbbVie Announces U.S. FDA Approval of EPKINLY® (epcoritamab-bysp) in Combination with Rituximab and Lenalidomide for Relapsed or Refractory Follicular Lymphoma

EPKINLY plus rituximab and lenalidomide (EPKINLY + R2) is now the first and only bispecific antibody combination therapy available for patients with relapsed or refractory follicular lymphoma after at least one line of systemic therapy

2 days ago

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