Incyte Lymphoma Treatment Gets FDA Approval
INCY
Published on 06/18/2025 at 16:28
By Kelly Cloonan
Incyte said it received approval from the Food and Drug Administration for monjuvi, in combination with rituximab and lenalidomide, as a treatment for follicular lymphoma.
The biopharmaceutical company said Wednesday the approval was based on Phase 3 trial data, which showed patients treated with the drug combination achieved a median progression-free survival of 22.4 months compared to 13.9 months in the control group.
The treatment is the second approved indication for monjuvi in the U.S., the company said. It is also the first FDA-approved CD19- and CD20-targeted immunotherapy combination for adult patients with follicular lymphoma.
Such patients have been waiting for new options that improve progression-free survival without a substantial increase in side effects, Chief Executive Herve Hoppenot said, adding the combination could set a potential new treatment standard.
The trial data showed serious adverse reactions in 33% of patients who received the treatment, including serious infections in 24% of patients, the Wilmington, Del., company said.
Follicular lymphoma represents up to 30% of non-Hodgkin lymphoma. It has historically been challenging to treat given its tendency for frequent relapse and potential to turn into large B-cell lymphoma, the company said.
Write to Kelly Cloonan at [email protected]
(END) Dow Jones Newswires
06-18-25 1627ET