Approvals extend use of Roche, AbbVie drugs in lymphoma

Patients in the US and EU with follicular lymphoma (FL) have new treatment options, thanks to regulatory approvals for Roche's Lunsumio and AbbVie/Genmab's Epkinly.

First up, the European Commission cleared a subcutaneous formulation of CD20xCD3 bispecific antibody Lunsumio (mosunetuzumab) for adult patients with relapsed or refractory FL who have previously been treated with two or more systemic therapies.

The approval puts Lunsumio on the same footing as Epkinly (epcoritamab) in FL – a form of non-Hodgkin lymphoma (NHL) – as AbbVie and Genmab's similarly-acting drug was cleared in the EU for the same third-line use last year. 

Epkinly is also delivered by subcutaneous injection, while Lunsumio was previously approved for this indication as an intravenous formulation, requiring patients to have a two- to four-hour infusion at a clinic. A decision on Roche's application for subcutaneous Lunsumio in the US, meanwhile, has been delayed, but should be forthcoming before the end of the year.

Roche said the new version – which was found to be non-inferior to IV Lunsumio in the GO29781 study – can be administered by a healthcare provider in as little as one minute. The company also pointed to the fixed-duration dosing schedule of Lunsumio as a potential differentiator for the drug, as Epkinly administration continues until disease progression or toxicity, and so could be a more costly option.

So far, Epkinly is thought to have been more successful commercially, making $333 million for AbbVie and Genmab in the first nine months of 2025, while Roche recorded around $96 million in Lunsumio sales in the same period.

However, it should be noted that Epkinly is also approved for diffuse large B-cell lymphoma (DLBCL), while Roche markets another CD20xCD3 bispecific – Columvi (glofitamab) – for that form of NHL and made $255 million in sales for that product in the first three quarters of the year.

Epkinly moves earlier in FL treatment

AbbVie and Genmab scored another approval for Epkinly this week that could lend additional momentum to the drug, getting a green light from the FDA for the drug in a regimen with rituximab and lenalidomide for relapsed/refractory FL, making it the first drug in the class cleared for combination treatment.

The approval, based on the EPCORE FL-1 study, moves Epkinly into the second-line setting – another first for the CD20xCD3 class – and also includes a fixed-duration regimen. Roche is running the CELESTIMO trial to try to move Lunsumio into second-line, but the readout for that has been delayed until next year.